‘‘ΕΛΑΧΙΣΤΑ ΕΠΕΜΒΑΤΙΚΗ ΧΕΙΡΟΥΡΓΙΚΗ, ΡΟΜΠΟΤΙΚΗ ΧΕΙΡΟΥΡΓΙΚΗ ΚΑΙ ΤΗΛΕΧΕΙΡΟΥΡΓΙΚΗ’’
ΕΘΝΙΚΟ ΚΑΙ ΚΑΠΟΔΙΣΤΡΙΑΚΟ ΠΑΝΕΠΙΣΤΗΜΙΟ ΑΘΗΝΩΝ ΙΑΤΡΙΚΗ ΣΧΟΛΗ
ΔΙΠΛΩΜΑΤΙΚΗ ΕΡΓΑΣΙΑ
ΘΕΜΑ:
MINIMALLY INVASIVE SURGERY IN BENIGN ANORECTAL DISEASES, A SYSTEMATIC REVIEW
ΜΕΤΑΠΤΥΧΙΑΚΟΣ ΦΟΙΤΗΤΗΣ:
ΞΑΝΘΗΣ ΑΘΑΝΑΣΙΟΣ Α.Μ.: 2014735 ΑΘΗΝΑ, ΜΆΙΟΣ 2017
ΠΡΑΚΤΙΚΟ ΚΡΙΣΕΩΣ
ΤΗΣ ΣΥΝΕΔΡΙΑΣΗΣ ΤΗΣ ΤΡΙΜΕΛΟΥΣ ΕΞΕΤΑΣΤΙΚΗΣ ΕΠΙΤΡΟΠΗΣ ΓΙΑ ΤΗΝ ΑΞΙΟΛΟΓΗΣΗ ΤΗΣ ΔΙΠΛΩΜΑΤΙΚΗΣ ΕΡΓΑΣΙΑΣ
Του Μεταπτυχιακού Φοιτητή Αθανάσιου Ξάνθη
Εξεταστική Επιτροπή
Δημήτριος Δημητρούλης, Επικ. Καθηγητής Χειρουργικής (Επιβλέπων)
Νικόλαος Νικητέας, Καθηγητής Χειρουργικής
Ιωάννης Γκρινιάτσος, Αναπλ. Καθηγητής Χειρουργικής
H Tριμελής Εξεταστική Επιτροπή η οποία ορίσθηκε από την ΓΣΕΣ της Ιατρικής Σχολής του Παν. Αθηνών Συνεδρίαση της...ης ... 20.... για την αξιολόγηση και εξέταση του υποψηφίου κου Αθανάσιου Ξάνθη, συνεδρίασε σήμερα .../.../....
H Eπιτροπή διαπίστωσε ότι η Διπλωματική Εργασία του Κυρίου Αθανάσιου Ξάνθη με τίτλο: Minimally Invasive Surgery in Benign Anorectal Diseases, a systematic review, είναι πρωτότυπη, επιστημονικά και τεχνικά άρτια και η βιβλιογραφική πληροφορία ολοκληρωμένη και εμπεριστατωμένη.
Η εξεταστική επιτροπή αφού έλαβε υπ’ όψιν το περιεχόμενο της εργασίας και τη συμβολή της στην επιστήμη, με ψήφους ... προτείνει την απονομή του Μεταπτυχιακού Διπλώματος Ειδίκευσης (Μaster's Degree), στον παραπάνω Μεταπτυχιακό Φοιτητή.
Στην ψηφοφορία για την βαθμολογία ο υποψήφιος έλαβε για τον βαθμό «ΑΡΙΣΤΑ»
ψήφους ..., για τον βαθμό «ΛΙΑΝ ΚΑΛΩΣ» ψήφους ..., και για τον βαθμό «ΚΑΛΩΣ» ψήφους ... Κατά συνέπεια, απονέμεται ο βαθμός
«...».
Tα Μέλη της Εξεταστικής Επιτροπής
Δημήτριος Δημητρούλης, Επιβλέπων (Υπογραφή)
Νικόλαος Νικητέας, (Υπογραφή)
Ιωάννης Γκρινιάτσος, (Υπογραφή)
TABLE OF CONTENTS
PART I 5
Introduction 5
1.Haemorrhoids 6
1.1 Aetiology and anatomy 6
1.2 Symptoms leading to surgical intervention 7
1.3 Examination and classification 7
1.4 Management and treatment options 8
1.5 Office based procedures 8
1.6 Minimally invasive techniques 9
1.7 Stapled haemorrroidopexy 9
1.7.1 Indications and contraindications 9
1.7.2 Informed consent 10
1.7.3 Patient preparation 11
1.7.4 Patient position 11
1.7.5 Technique 11
1.7.6 Complications 12
1.8 Ultrasonic Doppler Guided Transanal Haemorrhoidal Ligation 13
1.8.1 Indications and contraindications 13
1.8.2 Technique 13
1.8.3 Complications 14
2. Anal Fistula 14
2.1 Aetiology and anatomy 14
2.2 Symptoms leading to surgical intervention 14
2.3 Examination and classification 15
2.4 Management and treatment options 16
2.5 Minimally invasive techniques 16
2.6 Fibrin glue 16
2.7 Bio-prosthetic Collagen plug 17
2.7.1 Indications and contraindications 17
2.7.2 Patient preparation and positioning 17
2.7.3 Technique 18
2.7.4 Complications 18
2.8 Ligation of the intersphincteric fistula tract (LIFT) 18
2.8.1 Indications and contraindications 19
2.8.2 Patient preparation and positioning 19
2.8.3 Technique 20
2.8.4 Complications 20
2.9 Other minimally invasive techniques 20
2.9.1 Fistula Laser Closure (FiLaC) 20
2.9.2 Video Assisted Anal Fistula Treatment (VAAFT) 21
2.9.3 Adipose Derived Stem Cells (ASCs) 21
3. Faecal incontinence 21
3.1 Aetiology and anatomy 21
3.2 Symptoms leading to surgical intervention 22
3.3 Examination and classification 22
3.4 Management and treatment options 23
3.5 Minimally invasive surgical techniques 23
3.6 Radiofrequency Energy Delivery (SECCA) 23
3.6.1 Indications and contraindications 24
3.6.2 Technique 24
3.6.3 Complications 24
3.7 Sacral Nerve Stimulation (SNS) 25
3.7.1 Indications and contraindications 25
3.7.2 Preoperative planning 26
3.7.3 Patient preparation and positioning 26
3.7.4 Technique 26
3.7.5 Complications 27
PART II 28
Objective 28
Materials and methods 28
Results 29
Discussion 33
Conclusion and comments 35
ABSTRACT 35
ΠΕΡΙΛΗΨΗ 36
REFERENCES 37
PART I
INTRODUCTION
Benign anorectal conditions represent a significant workload for the general surgeon and colorectal specialist. Most people experience some form of anorectal disorder during their lifetime. The most common of these conditions are haemorrhoids, anal fissure, pelvic floor weakness, anal sepsis and fistula. Several new procedures and techniques have been developed over the past decade to treat these conditions.
Haemorrhoids are one of the most common reasons patients are referred to a colon and rectal surgeon accounting for up to 44% of these problems while anal fissure and perianal abscesses account for 19%. The management rate of perianal problems is significantly higher for male patients than for female patients and the rate is
significantly higher for patients aged 25-44 years than for all other age groups. Newer less invasive techniques such as rubber band ligation, infrared coagulation have been widely used in the treatment in early disease, while stapled haemorrhoidectomy and ultrasonic Doppler-guided transanal haemorrhoidal ligation have gained important space in the treatment of more advanced disease.
By district definition an analysis fistula is an abnormal passage from one epithelial surface to another epithelial surface. A variety of surgical procedures have been used to treat anal fistulas but less invasive techniques such as fibrin glue and the anal fistula plug are nowadays options in a variety of cases.
Pelvic floor weakness can lead to full thickness rectal prolapse for which over 100 operations have been described, both perineal and abdominal approaches as well as laparoscopic procedures, owing to the difficulty and complexity of treating this condition. The artificial bowel sphincter and newer minimal invasive techniques such as sacral nerve stimulation and the SECCA procedure have been added to the surgical armamentarium.
Anal fissures are the more common benign anorectal conditions treated both by surgeons and medical physicians. There is a variety of conservative and less invasive therapeutic options to treat this painful disorder.
The aim of this review is to highlight all the innovative developments that lead to this shift towards minimal invasive approaches in treating conditions that traditionally required complex surgical procedures. On the other hand is important to clarify the strict indications to select one of these approaches. Performing a minimal invasive operation in selected cases may improve the overall results but being applied in all the cases and replacing the traditional surgery has not been proven yet and in some cases there is still a place for traditional operative techniques.
1. HAEMORRHOIDS
1.1 AETIOLOGY AND ANATOMY
Haemorrhoids are swellings of the submucosal veins at the top of the anal canal. The aetiology and pathogenesis of haemorrhoids is unclear. Currently, haemorrhoids is the the pathologic term describing symptomatic and abnormally downward displacement of anal cushions. Haemorrhoidal cushions as the anal venous plexi are normal
anatomical structures from infancy(1). Prolapse of the anal cushions and vascular hyperplasia, first proposed to be the pahogenesis of haemorrhoidal disease(2).
Neovasculature in the expression of CD105 might cotribute to their development(3) and mascularis mucosa dysplasia and myofibrotic malformation have been recently added in their complex pathogenesis(4).
Haemorrhoids may be caused by more than one factor. Although some evidence suggests that haemorrhoids are familial, it is not known if this is caused by hereditary influences or environmental factors. Despite a vast literature the pathogenesis and even the function of this tissue remains controversial. The high prevalence of anascopic evidence of this pathologic entity and its problematic relationship to symptoms suggests that perhaps these findings may be more a consequence of the aging process than truly a disease entity(5).The development of haemorrhoids before age 20 years is unusual. A peak in prevalence is noted from age 45-65years with a subsequent decrease after age 65 (6, 7).
The following have been suggested as factors that contribute to the development of haemorrhoids(8):
Heredity
Anatomic features
Nutrition
Occupation
Climate
Phycological problems
Senility
Endocrine changes
Food and drugs
Infection
Pregnancy
Exercise
Coughing
Straining
Vomiting
Constrictive clothing
Constipation
1.2 SYMPTOMS LEADING TO SURGICAL INTERVENTION
The most frequent symptoms are bleeding, protrusion, anorectal discomfort and pain.
1. Bleeding is usually painless in nature and is described as fresh red blood on the tissue paper, in the bowl and around the stools. Haemorrhoids account for lower GI bleeding in 2-9% of patients. The presence of per rectal bleeding and its association with colorectal cancer can cause anxiety and referral for
investigation with proctoscopy and colonoscopy.
2. Protrusion depends on stage and is associated with prolapse of these haemorrhoids, often requiring manual reduction.
3. Anorectal discomfort is usually due to irritation of the perianal skin
4. Severe and constant pain is related to acute thrombosis and most of the times is associated with a palpable perianal mass
5. Constipation is not a symptom of haemorrhoids but defacation may be difficult when thrombosis or gangrene produces pain. Patients tend to avoid the toilet if haemorrhoidal symptoms are exacerbated by defacation and this can lead to refusal of the urge to pass stools and can result to constipation or even obstipation
The initial management of haemorrhoids is community based. Dietary manipulation, bulk forming laxatives and advice should be offered first. Although persistent symptoms merit referral for investigation and treatment.
1.3 EXAMINATION AND CLASSIFICATION
Physical examination should include digital examination, proctosigmoidoscopy to exclude neoplasia or inflammation and anoscopy to clearly inspect the haemorrhoidal tissue and anal canal with assessment of size, degree of prolapse and any fragility or bleeding. Colonoscopy or a barium enema study must be performed in all patients who have rectal bleeding when the source is not readily apparent from these
examinations. In patients older than 50 years of age, an evaluation of the colon should be performed at some time even if haemorrhoids are the apparent cause of patient’s symptoms(9).
Haemorrhoids are classified by location with the pectinate line being the anatomical landmark (external, internal or mixed) or by degree, which is applied only to the internal variety. Goligher’s system is the most widely adopted system for grading internal haemorrhoids (10).
First-degree: the veins of the anal canal are increased in number and size, and may bleed at the time of defecation. They do not prolapse but merely project into the lumen
Second-degree: they present outside the anal canal during defecation but they return spontaneously to within the anal canal, where they remain the rest of the time
Third-degree: they protrude outside the anal canal and require manual reduction
Fourth-degree: they are irreducible and constantly remain in the prolapsed state
1.4 MANAGEMENT AND TREATMENT OPTIONS
Bleeding, if occasional and related to staining or to diarrhoea, can often be managed according to the cause of bleeding. If constipation is the reason of exacerbation of bleeding a high fibre diet should be the initial approach(11), while stool softeners and laxatives may improve the symptoms. Diarrhoea or frequent defecation may be managed with antidiarrheal medication and diet.
Attention should also be given to improvement of anal hygiene. Anorectal discomfort due to pruritus ani may improve just by good hygiene or by adding commercial topical creams and lotions. However, the published literature lacks strong evidence supporting the true efficacy of topical treatment for symptomatic haemorrhoids.
Attempting reduction of prolapsed haemorrhoids is important because persistent prolapse predisposes the patient to thrombosis and possibly even necrosis.
The physician should consider the value of warm sitz baths in the treatment of pain caused by haemorrhoids. There is a little question that pain is ameliorated by the application of heat and it is related to the decrease of the resting pressure of the anal canal(12).
For an oral preparation, flavonoids are the most common phlebotonic agent used for treating haemorrhoids(13). It is apparent that flavonoids could increase vascular tone, reduce venous capacity, decrease capillary permeability, facilitate lymphatic drainage and has anti-inflammatory effects (14). A large meta-analysis of phlebotonics for haemorrhoids in 2012 showed that phlebotonics had significant beneficial effects on bleeding, pruritus, discharge and overall symptom improvement. Phlebotonics also alleviated post-haemorrhoidectomy symptoms(15).
1.5 OFFICE BASED PROCEDURES
Many office based procedures such as rubber band ligation, injection sclerotherapy, infrared coagulation, cryotherapy, radiofrequency ablation and laser therapy are effectively performed for grade I and II haemorrhoids and some cases of grade III haemorrhoids with or without local anaesthesia. Rubber band ligation (RBL) appears to have the lowest incidence of recurrent symptom and the need of retreatment and is
recommended as the initial mode of therapy. It has been compared in literature with the excisional techniques and it has been associated with less complications and pain(16). However, it is contraindicated in patients with anticoagulants or bleeding disorders and those with concurrent anorectal sepsis. The proper position of rubber band should be at the base of the haemorrhoid bundle or over the bleeding site, but not too close to the dental line. Vacuum suction ligator may offer cleared visualisation of haemorrhoids and more precise placement of banding when compared to a
traditional forcep ligator(17).
1.6 MINIMALLY INVASIVE SURGICAL TECHNIQUES
This review aims to describe the minimally invasive techniques, which can be applied in advanced disease and in some centres have replaced the conventional treatment, and assess their efficacy. These techniques involve Stapled Haemorrhoidopexy and Transanal Haemorrhoidal Dearterialization.
1.7 STAPLED HAEMORRHOIDOPEXY
There has truly been a renascent interest in surgical haemorrhoidectomy since the introduction of the circular stapling device for the treatment of haemorrhoid prolapse by Longo in 1998, in the 6th World Congress of Endoscopic Surgery in Rome. Stapled Haemorrhoidectomy (SH) or procedure for prolapse and haemorrhoids (PPH)
includes submucosal excision of prolapsing haemorrhoidal tissue. It represents a non excisional approach for the surgical treatment of haemorrhoidal disease. This
procedure has introduced the concept of dealing with the rectal mucosal prolapse by resecting a mucosal cylinder above the dentate line through mechanical stapling(18).
It is aimed at repositioning the prolapsed haemorrhoid tissue through a circular resection of the inner layers. In association, the mechanical anopexy would also cause an interruption of the vascular supply to the hamorrhoid cushions leading to a volume reduction of the haemorrhoid tissue.
1.7.1 INDICATIONS AND CONTRAINDICATIONS
In accordance with the recommendations proposed in 1993 by the Standards Task Force of the American Society of Colon and Rectal Surgeons(19) and as these were revised later in 2005(20) and in 2011(21) after the reports of the complications that this procedure carries it was thought pudent to establish specific indications and contraindications for this procedure. The recommendations are the following:
Grade III haemorrhoidal disease
Grade II haemorrhoidal disease with circumferential involvement
Grade II haemorrhoidal disease associated with rectal mucosal prolapse
Grade II haemorrhoidal disease non responding to ligation therapy
The use of SH in grade IV haemorrhoidal disease is more controversial with some papers suggesting increased incidence of postoperative bleeding and recurrence(22), while other suggest acceptable results when compared to excisional techniques(23).
There are a few contraindications to perform SH, some of them are absolute and some other relative and they were documented in the same consensus paper of the Society of the American Colon and Rectal surgeons. The recommended absolute
contraindications are:
Anal stenosis
Coincidence of anal sepsis, abscess or complex fistula
Anal or rectal cancer
Coexistent proctitis (Crohn’s disease or radiation induced)
Anorectal sexually transmitted disease
The recommended relative contraindications are:
Grade IV haemorrhoidal disease
Previous major rectal surgery (e.g. low rectal or coloanal anastomosis)
Previous sphincter reconstruction
Patients practicing receptive anal intercourse
1.7.2 INFORMED CONSENT
The consent form should be unique for this operation . Because the procedure is undertaken within the rectum, itself, and in effect is associated with a staple line that is somewhat analogous to that of a distal rectal anastomosis, patients may experience urgency to defecate and may have transient problems with rectal discharge and irritation. With respect to pain and swelling, especially as a consequence of
thrombosed haemorrhoids that develop during the postoperative period, this must be considered a complication of the procedure. Anastomotic stenosis has been reported but be quite unusual withy the SH instrument, given its relatively large diameter.
1.7.3 PATIENT PREPARATION
In general, no specific preparation is necessary. However, it is a general practice to preoperatively administer one or two phosphate rectal enemas. Although no evidence derived from randomised controlled studies exist, a single -shot antibiotic prophylaxis should be provided (e.g. cefotaxime and metronidazole). In high risk patients, such as immunosuppressed patients, antibiotic prophylaxis is mandatory.
1.7.4 PATIENT POSITION
Surgeons should choose the position which they are most comfortable. As SH can be performed in either the prone jackknife position or in a lithotomy position it is a surgeons decision. Lithotomy position enables transvaginal intraoperative
examination. If such a position is selected the hips should be completely flexed to expose the entire perineum.
1.7.5 TECHNIQUE
Surgery is performed in a standardized technique as described using the commercially available PPH03 procedure set, which involves a circular anal dilatator (CAD), a haemorrhoid circular stapler (HCS), a purse-string suture anoscope and a suture threader(ST). The diameter of the CAD is 33mm and often appears in literature as CAD33.
Circular Anal Dilatator Insertion
The CAD is inserted without tension. It is recommended to gently dilatate the anus before inserting the obturator. The CAD is then anchored with four quadrant sutures at the anal verge. After the placement of the CAD, a gauze swab can be inserted into the distal rectum and withdrawn to expose the extent of haemorrhoidal and mucosal prolapse. The dentate line should be visible through the clear plastic of the CAD.
Purse-string Suture Placement
The purse-string suture anoscope is introduced through the CAD. Its rotation allows the placement of a circumferential purse string suture at the correct height
approximately 3 to 4 cm above the dentate line or 1 to 2 cm from the haemorrhoidal
apex. The suture is submucosally placed. Small bites placed close together are advised. A 2-0 Prolene on a 25- to 30-mm curved needle is used. One must confirm the correct height and the completeness of the purse string before inserting the HCS.
Stapler Insertion
The HCS is inserted under direct vision into the distal rectum fully opened. After ensuring that the head is positioned above the purse string the later is tied and the ends are pulled through the holes in the stapler device. The suture ends are then held to apply firm traction on the purse string and the stapler can be closed. The stapler is aligned along the axis of the anal canal. At the end of the closure the 4-cm mark should be at the anal verge. If the patient is a woman, it is advisable to pass a finger into the vagina, checking the posterior wall, to be certain that it has not been
incorporated. The stapler is then fired.
Checking the staple line and the resected specimen
The staple line should be checked for completeness and haemostasis. Oversewing a bleeding point with absorbable sutures is mandatory. After removing the HCS the tissue ring is checked macroscopically and is sent for histopathological examination.
Finally a degradable sponge dressing or haemostatic pad is inserted through the anus.
1.7.6 COMPLICATIONS
There are no specific circumstances indicating a higher or different risk of
complications after SH for prolapsing haemorrhoids in comparison with excisional haemorrhoidectomy. Although the procedure has been shown to be safe, there is always the risk of morbidity. Focusing only in this procedure there are some complications that are unique for this operation. These include
pneumoretroperitoneum, pneumomediastinum and subcutaneous emphysema(24), pelvic sepsis(25, 26), fournier gangrene(27), persistent severe pain and faecal urgency(28), rectal perforation(29), rectal stricture (30), rectal obstruction, rectovaginal fistula and obstructed defecation(31). Other more common
complications have been reportred and they could be further differentiated in early and late onset complications. been demonstrated that most common early and late complications after SH are postoperative bleeding, persistent pain and recurrent prolapse. If major bleeding occurs within the first 24 hours postoperatively,
reexploration under anesthesia is advisable., because direct bleeding from the staple line is probably the cause(32). An increase in incidence of inconsequential bacteremia has been reported in a prospective randomised trial and may complicate the
haemorrhoidopexy but has no serious consequences for healthy adults and despite some have recommended the routine application of antibiotics there is no evidence that this is appropriate or likely to be helpful. The majority of complications can be avoided by strict and meticulous technique and it has become clear that this operation should be performed only by surgeons experienced with this operation(33).
1.8 ULTRASONIC DOPPLER-GUIDED TRANSANAL HAEMORRHOIDAL LIGATION (DEARTERIALIZATION-THD)
This is an innovative, minimally invasive technique introduced by Morinaga in 1995.
The selective ligation of the terminal branches of the superior rectal artery is the cornerstone of the THD(34).
1.8.1 INDICATIONS AND CONTRAINDICATIONS
There is a confusion in the literature regarding the indications of this procedure and whether is truly applicable to grade IV haemorrhoidal disease. The published data support the use of THD in grades II and III if bleeding and pain persist in spite of conservative treatment (35-38). The safety of this operation in grade IV has been assessed in studies, which were either uncontrolled (39), either lack of a long term follow up(40).
1.8.2 TECHNIQUE
A progressive anal dilatation is performed, and a modified anoscope with built-in ultrasound transducer, light and special window Echo sounder is inserted, with reduction of any prolapsing tissue and anoderm, and rotated to locate the artery to be ligated. The circumference of the lower rectum is divided into 6 sectors (left
anterolateral, left lateral, left posterolateral, right posterolateral, right lateral and right anterolateral) corresponding with the clock positions 1,3,5,7,9 and 11 o clock. The vessel is then suture ligated. Te suture used is a 2-0 absorbable polyglycolic acid suture with a 5/8 inch needle and 26.5 mm. At each location the haemorrhoidal arterial branch is identified and ligated through the aperture in the anoscope with a figure of eight or purse string suture. In addition to the dearterialization of the haemorrhoidal plexus, the procedure often entails mucopexy, which is done with a continuous suture of the mucosa by means of clamping and causes firmer adhesion to the deeper layers of the rectal wall due to the fibrosis (39). Each time a suture is secured, adequacy of occlusion is confirmed by loss of Doppler signal. The
completeness of suture haemorrhoidopexy is also confirmed circumferentially and, if needed, additional plication sutures are placed to achieve the desired results.
1.8.3 COMPLICATIONS
The reported complications are pain and tenesmus, postoperative bleeding, temporary incontinence, recurrent rectal prolapse, constipation, local sepsis, urinary retention, pain at defecation, thrombosis of the residual haemorrhoids and anal fissure(34, 37, 40-44). In a multicentre study where eight hundred and three patients affected by grade II to IV symptomatic haemorrhoidal disease underwent a THD procedure the morbidity rate was 18%. Overall the THD appeared to be an effective and safe therapy for haemorrhoidal disease. To contain and reduce the symptoms, an accurate distal Doppler guided dearterialisation and a tailored mucopexy are mandatory(45).
2. ANAL FISTULA
2.1 AETIOLOGY AND ANATOMY
The majority of perianal sepsis is idiopathic or cryptoglandular in origin, and arises from the obstruction of the anal glands, leading to stasis of glandular secretions and if secondarily infected, suppuration and abscess formation. The abscess typically forms in the intersphincteric space but can extend into the ischiorectal fossa or supralevator, suprasphincteric spaces. A fistula tract may subsequently form.
A minority of cases are secondary to an underlying process, including Crohn’s disease, local radiation, malignancy, trauma, tuberculosis, HIV, hidradenitis suppurativa, lymphogranuloma venereum, perianal actinomycosis and rectal duplication. Rectal and foreign body trauma should also be considered as possible etiological causes. In these situations, the fistula tract is often atypical.
2.2 SYMPTOMS LEADING TO SURGICAL INTERVENTION
The most frequent presenting complaints of patients with an anal fistula are swelling and discharge. The former two symptoms usually are associated with an abscess when the external or secondary opening has closed or has failed to develop. Discharge may be from the external opening or may be reported by the patient as mucus or pus mixed with the stool. Most patients with an overt fistula have an antecedent history of
abscess that drained spontaneously or for which surgical drainage had been performed.
2.3 EXAMINATION AND CLASSIFICATION
Numerous methods can be employed to identify the type of fistula, the course of the tract and the location of the internal opening. Physical examination still remains the initial approach, as a careful palpation may reveal the thickened tract proceeding into the anal canal if the fistula assumes a relatively superficial position. Bidigital
examination, placing the thumb on the outside and the index finger within the anal canal, may also help to reveal the course of the tract. Failure to identify the tract by palpation implies that it is deep and therefore more likely to be a transsphincteric fistula. Localization of the internal opening in most cases enables the classification of perianal fistulas. The external opening of an intersphincteric fistula is almost always located near the anal verge, whereas the distance between the external opening of a transphincteric fistula and the anal verge is several centimeters or more.
Goodall’s rule has been used for many years to predict the course of fistulous tracts according to the external opening. When the external opening lies anterior to the transverse plane, the internal opening tends to be located radially. On the other hand, when the external opening lies posterior to this plane the internal opening is usually located in the posterior midline. The predictive accuracy of this rule has been
questioned in the past and in a recent prospective study the rule found to be accurate only when applied to complete submuscular anal fistulas with posterior external anal openings. The rule was found inaccurate in describing the course of complete
submuscular anal fistulas with an anterior external opening, where men found to have an upredictable tract and in 90% of women the tract had a midline anterior origin (46).
Many radiological techniques have been applied in order to identify the course of the tract such as endoscopic ultrasound, fistulografies, CT and MRI. Fistulografy has been surpassed in the last decades by endosonography and MRI, as both techniques have the advantage of direct visualization of the fistoulous tract and the imaging of the anal sphincter with the MRI now to be considered as the the investigation of choice to define complex anorectal sepsis and fistulas(47, 48). The endoscopic
examination and small bowel series are strongly encouraged in the presence of known or suspected inflammatory bowel disease. Also different injection techniques such as dye injection or milk injection or hydrogen Peroxide injection have been used mostly to identify the internal openings rather than the course of the tract.
Parks had presented a classification of anal fistulas after the analysis of 400 cases since 1976 and it is widely used to present(49):
Intersphincteric: simple low tract, high blind tract, high tract with opening into rectum, high fistula without a perineal opening, high fistula with extrarectal or pelvic extension,fistula from pelvic disease.
Transsphincteric: uncomplicated or with a high blind tract
Suprasphincteric: uncomplicated or with a high blind tract
Extrasphincteric: secondary to transphincteric fistula, trauma, anorectal disease or pelvic inflammation
Submucous
Combined
2.4 MANAGEMENT AND TREATMENT OPTIONS
The principles of treatment are to define the anatomy of the fistula track and its secondary extensions, to drain any coexisting pus and then to provide definitive treatment by laying open. In accordance with the recommendations proposed in 1996 by the Standards Task Force of the American Society of Colon and Rectal
Surgeons(50) and as these were revised later in 2005 (51) and in 2011 (52), the surgeon should be able to open the tract at the same time of the initial operation without fear of causing significant impairment for bowel control. If there is concern about the safety of dividing at the level of the internal opening, a seton can be temporarily employed. The surgeon who initially treats the patient has the best opportunity to identify the tract, find the internal opening and effect a cure. A fistula tract should not always be identified and laid open at the same time of draining an anorectal abscess. Primary fistulotomy, during drainage may lead to an increased functional disturbance compared with fistulotomy as a second stage procedure. If feasible, it should be recognized if a fistula tract is present at all, in cases with unclear involvement of the sphincter muscles, a seton may be placed. The patient will be readmitted to the hospital after two weeks for another staged exploration under anaesthesia. Depending on the local situation, a fistulotomy may be performed then, or only after further revisional examinations in two weekly intervals until final fistulotomy.
2.5 MINIMALLY INVASIVE TECHNIQUES
The risk of potential damage to the anal sphincters in patients with high fistulae has lead on the one hand in more complex operations with advancement flaps and on the other hand in less invasive sphincter preserving techniques such as fibrin glue, fistula plug, ligation of the intersphincteric fistula tract (LIFT), expanded adipose derived stem cells (ASCs), video-assisted anal fistula treatment (VAAFT) and Radial-emitting laser probe (FiLaC).
2.6 FIBRIN GLUE
Due to a variety of application of fibrin glue in a fistula tract the technique cannot be presented on a standardized manner. The mode of action is thought to be by
stimulating the growth of fibroblasts and pluripotent endothelial cells into the fistula tract to seal it off. Between days 7 and 14, these cells lay collagen and an extracellular matrix during the process of wound healing.
2.7 BIO-PROSTHETIC COLLAGEN PLUG
The concept of a plug was first introduced in 2006 (53) with the idea that securing the plug into the primary opening of a fistula tract could close the tract more reliably than previous procedures, without compromising continence because the sphincters were not incised or divided. The material initially was designed for bridging large tissue defects in the abdominal and chest walls. The plug is made of lyophilized porcine small intestinal submucosa, which has an inherent resistance of infection (54, 55) and generates no foreign body or giant cell reaction(56) and is repopulated by host cell tissue within 3 months (54). Cook Medical’s Surgisis Fistula Plug was approved by the U.S. Food and Drug Administration (FDA) in 2005 and became the first
commercially available anal plug. Gore and Associates entered the fistula plug called BIO-A Fistula Plug which was also approved by FDA in 2009.
2.7.1 INDICATIONS AND CONTRAINDICATIONS
Patients, who are eligible for treatment with anal plug should have undergone previous surgical drainage of the perianal abscess and have had a draining seton placed 6-12 weeks in advance of fistula plug placement. A plug may be placed primarily only in those patients who have no evidence of infection and a well formed fistula tract. The current recommendations are:
Transsphincteric fistula
Intersphincteric fistula only when fistulotomy is contraindicated
The contraindications are:
Persistent abscess or infection
Intersphincteric fistula when no contraindication to fistulotomy exists
Inability to identify the internal and external openings
Allergy to plug material
2.7.2 PATIENT PREPARATION AND POSITIONING
No consensus about bowel preparation exist, with some authors advocating complete mechanical preparations and others simply administering an enema on the morning of the procedure. It should be stressed that there should be no active infection present at
the time of surgery and the patients have a well formed tract. A broad spectrum preoperative antibiotic is recommended. Patient positioning and anestesia can be performed according to the surgeons preference. Both prone jack-Knife position and lithotomy position are acceptable.
2.7.3 TECHNIQUE
The previously placed draining seton is noted and the perineum and anal canal are again inspected to verify that there is no active infection prior to preparing the fistula plug. A 2-0 suture is secured to the seton. The seton is then cut and pulled out of the fistula so that the suture now crosses the fistula leaving the needle on the internal opening. The fistula tract is then irrigated with dilute hydrogen peroxide using an angio catheter or gently debrided with a cytobrush or small curettes. Finally the tract is irrigated with saline.
The plugs require rehydration fully submerged in sterile saline for no more than two minutes. The previously placed suture is secured to the plug material on the external opening side of the plug. The suture is then used to draw the plug material through the fistula tract. The plug is then secured with an absorbable suture such as a 2-0coated polyglyconic acid, anchoring it to the sphincter complex and covering the plug. Some surgeons prefer to create small mucosal flaps to better cover the plug to the internal opening. The excess material is trimmed at the skin and the external opening is either left open or loosely closed without fixing the plug at the external opening.
2.7.4 COMPLICATIONS
The most frequent complication other than failure to close the fistula tract is abscess.
The incidence has been highly variable but generally infrequent. Infectious complications are managed with antibiotics or may at times require drainage
procedures either in the office or in the operating room. This may require replacement of the seton or simple drainage of the external opening with either packing or a
drainage catheter. Pain is generally minimal and easily managed with oral analgesics.
Plug extrusion or fall out has frequently been listed among the complications or technical failures of these procedures(57-67).
2.8 LIGATION OF THE INTERSPHINCTERIC FISTULA TRACT (LIFT)
The LIFT procedure is a promising new sphincter sparing procedure first described in 2007 (68). The main concept of this procedure is the identification of the
intersphincteric fistula tract with its subsequent ligation. There is no division of the sphincter muscle and theoretically continence should be preserved.
2.8.1 INDICATIONS AND CONTRAINDICATIONS
The current indications for this procedure as initially described by Rojanasakul et al (68) are:
Low transsphincteric fistulas
High transsphincteric fistulas
Potentially suprasphincteric/extransphincteric fistulas where the tract traverses the intersphincteric space
Recurrent fistulas
Pre-existing continence issues
Multiple tracks
The current contraindications are:
Active perineal sepsis
Active inflammatory bowel disease
Malignancy
2.8.2 PATIENT PREPARATION AND POSITIONING
There is no need to preoperatively admit the patient to hospital. A pre-LIFT drainage seton doesn’t appear to contribute to the success of the procedure(69). An outpatient preparation with two disposable phosphate enemas per rectum or a full bowel
preparation can be done at the surgeon’s direction. No preoperative antibiotic therapy is required. According to the surgeon’s preference a seton can be inserted 8-12 weeks prior to performing the LIFT. The patient is placed in the prone jackknife position.
Local anaesthetic with epinephrine is used to help decrease the amount of bleeding, which also helps with visualization.
2.8.3 TECHNIQUE
This technique vinvolves disconnection of the internal opening from the fistula tract at the level of the intersphincteric plane and removal of the residual infected glands, without dividing any part of the anal sphincter complex. Following the identification of the internal opening by injecting hydrogen peroxide from the external opening or gently probing the fistula tract, a 3-4 cm curvilinear incision is usually made to enter the intersphincteric groove. The fistula tract is then identified by a combination of blunt and sharp dissection, which is guided by the semirigid fistula probe. The fistula tract is then exposed and ligated with two absorbable sutures on both sides, that is at the entrance into the external and internal sphincter in the intersphincteric space.
Hydrogen peroxide can be introduced through the external opening to ensure there has been a secure ligation on the external sphincter portion of the intersphincteric tract and similarly hydrogen peroxide can can be introduced in the transsphincteric space to ensure closure of the tract traversing the internal sphincter. Currette of the fistula tract and drainage of the external opening by an additional incision or an insertion of a catheter can also be performed.
2.8.4 COMPLICATIONS
The experience with the LIFT continues to evolve. None of the series(68, 70-74) report any issues with continence and in case of failure, the operation can be readily repeated. The technique is simple and easy to learn.
2.9 OTHER MINIMALLY INVASIVE TECHNIQUES
The following three techniques are recently described in the literature and there are a few original articles with preliminary results with no reported RCTs to compare them with either the traditional techniques, either with more established sphincter sparing techniques such as LIFT, fistula plug and fibrin glue. Therefore they will be briefly mentioned in this review.
2.9.1 FISTULA LASER CLOSURE (FiLaC)
The use of laser in the treatment of anal fistula was initially described in 2011 in a pilot study by Wilhelm (75). This novel sphincter-saving technique uses an emitting laser probe, which destroys the fistula epithelium and simultaneously obliterates the remaining fistula tract. The procedure also includes the closure of the internal opening
by means of an anorectal flap. When some scar tissue prevents that, either mucosa or anodermal flap is used for closure of the internal opening.
2.9.2 VIDEO ASSISTED ANAL FISTULA TREATMENT (VAAFT)
This technique was reported in 2006 and currently the presenting article is the only available to date (76). This procedure is performed with a kit which includes a fistuloscope, an obturator, an unipolar electrode, an endobrush and a 0.5mL of synthetic cyanoacrylate glue. The procedure has two phases, one diagnostic followed by an operative phase.
2.9.3 ADIPOSE DERIVED STEM CELLS (ASCs)
The use of mesenchymal adult stem cells extracted from adipose tissue was first presented as an alternative treatment of perianal fistulae in patients with Crohn’s disease in 2005(77). The efficacy of the technique was further assessed in fistulae of cryptoglandular origin.
3. FAECAL INCONTINENCE
3.1 AETIOLOGY AND ANATOMY
Available studies indicate the prevalence of incontinence in the general population to be around 2% with an increased incidence in the elderly and those in psychiatric, geriatric and community based accommodations as high as 50%. It is the second most common cause of institutionalization in the elderly(78-82)(80). In otherwise healthy younger women, direct sphincter trauma or neuropathic injuries from vaginal deliveries are the principal causative factors. In male patients cognitive impairment, poor general health, surgery, and radiation for prostate cancer were associated with incontinence (83). There is an extensive literature linking faecal incontinence to obesity(84-87).The aetiologies in general include:
Mechanical defects: sphincter damage from obstetric trauma, fistulotomy, and scleroderma affecting the external sphincter
Neurogenic defects: including spinal cord injuries, pudendal nerve injury due to birth trauma or lifelong straining and systemic neuropathies such as
multiple sclerosis
Stool content related: such as diarrhoea and radiation proctitis
3.2 SYMPTOMS LEADING TO SURGICAL INTERVENTION
The most common reason that the patient visits a colorectal clinic is the affect that the faecal incontinence has to the quality of life that can result in significant physical and psychologic disability. A delayed presentation of post menopause women can also occur as the effects of menopause summate with those of pelvic muscular and neurologic injuries to produce overt symptoms of urinary incontinence, pelvic organ prolapse and faecal incontinence (88).
3.3 EXAMINATION AND CLASSIFICATION
The history is the key of a proper assessment of the patient. It should not be hurried and should not be obtained by a tick box method performed by the patient alone or a nonmedical person. The first aim of the history is to determine the nature of the symptoms, their severity and the degree to which they are affecting the patient’s life.
The frequency of incontinent episodes and the volume of stool lost on each occasion should be established. This last can range from a normal faecal bolus to a stain on the underwear. The ability to hold flatus should be noted. A gradation from watery to thin porridge to thick porridge to sausages to golf balls or rocks is a useful means of recording consistency. It is essential to determine the presence of urgency, which should be recorded objectively in minutes as stated by the patient when asked the question. The history should also record whether the patient uses pads and if so how many in 24 hours.
Evaluation includes visual and digital examination observing for gross tone or squeeze abnormalities. Inspection should be carefully carried out for faecal soiling around the anus, visible defects or scars from previous repairs or episiotomies or obvious cloacal deformities. Palpation should determine if the anal ring is intact, whether the anal muscle is diffusely weak and whether the muscle is normal and interrupted by a defect.
The clinical history and examination lack objectivity and therefore further investigation is required. In current practice almost all the patients undergoing investigation for incontinence will have anorectal manometry and anal
endosonography. Anal manometry quantitatively measures parameters of anal
function including resting and squeeze pressure (normal mean greater than 40 and 80 mm Hg respectively), sphincter length (4cm in men, 3 cm in women), and minimal sensory volume of the rectum. Anal endosonography has revolutionized the the diagnosis of many anal and pelvic floor disorders as it can demonstrate the thickness of the sphincter and the integrity of the sphincter ring. For patients with neurologigal deffects the pudendal nerve terminal motor latency (PNTML) can assess the
prevalence with increased latency in patients with faecal incontinence and it bis considered as the most useful of physiologic parameters for the evaluation of incontinence, for determining prognosis and for ascertaining response to treatment.
Patients with an evacuation difficulty, cineradiography, defecography, balloon evacuation and estimation of intestinal transit may also be performed.
3.4 MANAGEMENT AND TREATMENT OPTIONS
The key to decision making depends on whether the sphincter ring is intact or not.
Loose watery bowel movements may be difficulty to control even in the setting of normal sphincter function and evaluation of diarrhoea should be initiated before considering sphincter repair. Bulking agents, constipating medications, biofeedback, perineal exercises and anal plugs are recommended as first line therapy to minimize the frequency, thus decreasing incontinent episodes.
A patient with a complete sphincter will not respond to repair because surgery cannot improve on the anatomical situation. If the conservative treatment fails invasive treatment should be attempted. A patient with a disrupted sphincter ring will be helped by surgical repair.
In general, conservative treatment should be attempted unless it is obvious that some form of invasive treatment is inevitable. A cloacal deformity with severe incontinence is an example of a condition when repair is indicated. In most patients, however, conservative treatment should at least be tried. The patient should be fully informed and when the patient feels that conservative measures fail more invasive techniques should be offered.
3.5 MINIMALLY INVASIVE SURGICAL TECHNIQUES
For the purposes of this review we will assess the role of the two most applied
minimally invasive techniques which are the Radiofrequency Energy Delivery for the treatment of Faecal Incontinence (SECCA procedure) and the Sacral Nerve
Stimulation(SNS).
3.6 RADIOFREQUENCY ENERGY DELIVERY (SECCA)
Radiofrequency energy (RF) is widely used for cutting and coagulation. The application of the energy results in vibration of water molecules and subsequent frictional heating. The RF energy to the anal canal, was first used for the treatment of faecal incontinence in Mexico in 1999 by Curon Medical (Fremont, Ca, USA) after the RF procedure STRETTA, had shown a therapeutic effect in the treatment of gastro-oesophageal reflux (89)(PMID: 10882969). In 2002 the FDA approved the SECCA system for use specifically in the treatment of patients with incontinence to solid or liquid stool, occurring at least once per week, and who already had failed to
respond to more conservative treatment. This system is designed to deliver
temperature controlled RF energy to the muscle of the anal canal to induce fibrosis in hope that this would improve anal canal closure. In theory, RF-induced injury to the internal anal sphincter should, ideally, cause collaged deposition and fibrosis with the potential for tightening of the affected area.
3.6.1 INDICATIONS AND CONTRAINDICATIONS
Individual analysis of the available data on this procedure remain limited and the most of the published trials include patients with incontinence of varying aetiologies. The procedure has been used mainly for patients with passive incontinence associated, therefor with internal sphincter weakness. The main indication is the failure of the conservative treatment and the main contraindication is a disrupted sphincter ring(90).
3.6.2 TECHNIQUE
The procedure is a day case outpatient procedure undertaken in an ambulatory surgical or endoscopy unit, under local anaesthesia with sedation. The SECCA System is composed of a clear anoscopic barrel with four nickel-titanium curved needle electrodes of 22 gauge and 6mm in length. The needle electrodes are deployed through the mucosa of the anal canal and into the internal sphincter muscle. When this occurs, there is a reduction in electrical impedance, indicating penetration of the needle below the mucosal surface. Temperature is monitored automatically and a temperature control mechanism adjusts the RF output to achieve a target temperature of 85 degrees of Celsius at the tip of the needle electrode. Anoderm temperature is continuously monitored and energy delivery automatically ceases if the temperature exceeds a pre-set limit of 42 degrees. A one -minute treatment is applied to each set and ideally a total of 20 sets of four lesions each are created, beginning 5mm distal to the dentate line and at 5mm increments proximal to the original treatment site. All four quadrants are treated in a similar manner. Care must be taken during the anterior treatment in women to avoid penetrating the vagina. Depending on the number of sets the procedure takes approximately 30 minutes.
3.6.3 COMPLICATIONS
Manometry and endoanal ultrasound do not show significant changes post procedures.
The treatment has a slight decrease, though not clinically significant at one year follow up.
3.7 SACRAL NERVE STIMULATION (SNS)
SNS was first attempted in patients who had evidence of pelvic floor muscle
dysfunction without any evidence of structural sphincter injury(91-94). With less rigid inclusion criteria, SNS was found to be of benefit in patients with faecal incontinence secondary to idiopathic weakness of the pelvic floor (95) and later on the SNS was offered to patients in whom any defect of the external sphincter was less than 30% of the circumference of the anal ring.
3.7.1 INDICATIONS AND CONTRAINDICATIONS
The spectrum of indications for SNS is continually evolving. The findings that the effect of SNS is not confined to muscle relevant to continence and that the result of a positive test stimulation is highly predictive of the clinical outcome of chronic therapeutic stimulation has led to an increased number of patients that undergoing a test stimulation regardless the underlying pathology and the percentage of the defect of the external anal sphincter. Now indications include iatrogenic injuries to the internal sphincter (96), neurologic causes including incomplete spinal cord
injuries(95, 97, 98), scleroderma(99), rectal prolapse(100), anal fissure(101) faecal incontinence secondary to low anterior resection(102) and refractory ulcerative proctitis (103).
The desision making relies solely on documentation of the pretreatment bowel pattern and its changes during temporary stimulation (93). Permanent stimulation with a fully implanted device is usually indicated if the trial stimulation results in more than 50%
improvement symptom. The device should be implanted only after failure of the conservative treatment (104, 105) and sign an informed consent.
The current contraindiacations are(105):
More than 90 degrees defect in the sphincter ring
Pathologic conditions of the sacrum preventing adequate electrode placement ( such as congenital malformations)
Present external rectal prolapse
Chronic bowel diseases
Rectal surgery within previous 12 months and within 24 months for cancer
Chronic diarrhoea, unmanageable by diet or drugs
Stoma present
Skin disease and especially septic in the area of implantation
Micturition disorders that are considered contraindications for SNS
Pregnancy
Psychological instability, mental instability or retardation that would impede understanding and handling the device programmer
The presence of devices incompatible with the implanted neurostimulator such as cardiac pacemaker or implantable defibrillator)
The need for magnetic resonance imaging in diagnosing or treating any other medical condition as the current generation of stimulation systems is not MRI safe
3.7.2 PREOPERATIVE PLANNING
A preoperative sacral imaging in two planes will identify individual variances in bone anatomy and sacral foramina configuration. A change during temporary stimulation is necessary. It is also helpful to know whether the patients retain voluntary sphincter and pelvic floor contractions of reflex contraction can be provoked by a pin-prick test or coughing or sneezing.
3.7.3 PATIENT PREPARATION AND POSITIONING
The position of the implantable pulse generator (INS)should be discussed with the patient and marked preoperatively. The patient must be able to reach it with the handheld programmer to activate and deactivate it or to change stimulation amplitude in a preset range. Interference with personal habits or clothing should be avoided.
Preoperative bowel cleansing is not necessary.
The procedure can be performed under local or general anaesthesia. Long acting neuromuscular relaxants are contraindicated and the diathermy that is used is a bipolar, in order to avoid damage of the lead electrode. The patient is placed in the prone jackknife position and the buttocks are gently strapped apart and draped leaving the area over the sacrum and the perineum exposed this allows direct visualization of the anus. The legs are extended with the feet and great toe exposed beyond the drapes.
3.7.4 TECHNIQUE Temporary electrode
The sacral foramina lie about one fingerbreadth lateral to the midline. The S3
foramina are level with a transverse line joining the upper margin of the greater sciatic notch on each side. This is the same level as the most prominent part of the sacrum as demonstrated by the point at which a pen balances evenly on the skin when viewed laterally. The S3 site is preferred as this gives the best response, but if not successful S2 and S4 can be tried. The third sacral nerve root is the major component of the pudental nerve and contains mixed autonomic and somatic motor fiers and sensory fibers.
A needle electrode is inserted through the skin and advanced with a slight lateral inclination. If successful it will be felt to pass through the posterior sacral foramen to a depth of several centimeters. It is then connected to an extracorporeal pulse
generator using the attachment and the current is switched on. Several passes may be required in order to determine the best response at the lowest voltage possible. When the the optimal response has been ascertained, a wire electrode is passed down the needle that is then withdrawn to leave the wire in situ, but ensuring that a motor response is still preserved. The electrode is secured to the skin by an adhesive dressing and the lead is then connected to an extracorporeal devise having placed an earth pad to the skin by an adhesive to complete the electrical circuit.
Permanent electrode
After a 50% reduction in the frequency of incontinent episodes has been documented by the patient in a personal diary, the temporary electrode can be changed by a permanent one either with the percutaneous Sheldinger technique under radiologic guidance either with an open surgical approach. Currently the percutaneous approach is the most commonly performed technique with only about 10% being non eligible for this procedure. The permanent electrode is then connected to a pulse generator, which is then placed in a subcutaneous pocket, most commonly in the buttock, medial to the dorsal axillary line, distant from prominent bone structures such as the iliac crest. The pulse generator is activated early in the postoperative course, usually on the day of surgery. Patients must be able to cooperate because the programming is largely based on their perception of the stimulation effect.
3.7.5 COMPLICATIONS
The complications of the technique as reported in a systematic review (106) are divided to complications from the temporary wire electrode where the most frequent is the migration of the electrode and complications after the definitive implantation with the most reported in the literature the loss of efficacy or the suboptimal
therapeutic response. Other complications include infection, bleeding and pain during therapy.
PART II
OBJECTIVE
The purpose of this study was to identify the benefits and barriers to implement new minimally invasive techniques in the armamentarium of the treatment of benign anorectal diseases. There are traditional invasive techniques that still carry minimal morbidity and cannot be replaced by modern techniques. However all the innovative developments through the last two decades had lead to many new less invasive techniques which in some centres are nowadays the standard of treatment of these conditions. The aim of this review was to examine the current literature about minimally invasive techniques in the treatment of benign anorectal diseases, specifically in regard to their potential to replace traditional operations.
MATERIALS AND METHODS
In this study the following electronic databases were searched: Medline, Pubmed and Cohrane Library using the Medical Subject Headings (MeSH terms) hemorroids (MeSH Unique ID:D006484), fistula in ano (MeSH Unique ID: D012003) and fecal incontinence (MeSH Unique ID: D005242). Although the benign anorectal diseases include also the fissure in ano (MeSH Unique ID: D005401) the search was not expanded in the search of any technique regarding this anorectal disease as to my knowledge the lateral internal sphincterotomy is currently the only treatment of
choice worldwide. The search included meta-analysis, systematic reviews and reviews of the literature, randomized controlled trials, clinical trials and prospective studies, case series and case reports in English. The search also included hand searching the reference lists of the retrieved articles from the electronic databases. There were no limitations regarding the publication dates. Eleven thousand and ninety three (n=11093) original articles were found to examine the surgical treatment of these conditions. Many of these studies examined specifically the newly developed minimally invasive techniques applied in these diseases. Studies examining the traditional excisional and invasive techniques only where excluded, whereby in total eighty six studies (n= 86) remained for detailed evaluation.
RESULTS
In the current literature the minimally invasive techniques are compared with the traditional treatment according to the underlying pathology. Therefore, the results of this review will be presented separately for each of the three anorectal diseases and separately for each of the new treatment options.
Haemorrhoids
Excisional Haemorrhoidectomy VS Stapled Haemorrhoidopexy
There are numerous studies which highlight the significant reduction in the
postoperative pain with SH(23, 107-118). This is not surprising in light of the fact that there is no cutting within the anal canal. What is being excised is a circumferential column of mucosa and submucosa above the anal canal.
Interpretation of the literature is made difficult by heterogeneity of published clinical trials. The majority of the studies are comparing SH with excisional techniques and most of them have included patients with third or fourth degree haemorrhoids.
However other studies have included patients with second degree or have restricted their investigation to patients with fourth degree haemorrhoids. Moreover in many studies there has been no clear definition related to patient selection and degree of haemorrhoidal prolapse. On top of that many of these studies have only focused on short term outcome, whereas conclusions derived from controlled long term data are limited.
A published metanalysis(119), which included twenty seven RCTs comparing SH with conventional haemorrhoidectomy (n=2279) concluded that the majority of the studies reported less pain (95% of studies), shorter time of surgery (89% of studies), a reduced hospitalization (88% of studies) and a shorter convalescence time (93% of studies) following SH but a higher rate of prolapse and reintervention for prolapse. In general short term benefits of SH also included better wound healing and a higher patient satisfaction. In terms of cost effectiveness, there seems to be no fundamental difference between SH and excisional techniques.
In another metanalysis(120) solely focusing on long term outcomes which included fifteen RCTs comparing SH with excisional techniques (n=1201) with a minimum follow up of twelve months, a higher incidence of prolapse was documented.
Moreover patients who had undergone SH were more likely to undergo further treatment.
In conclusion experience in both patient selection and alternative procedures without a stapling device is mandatory. Respecting the indications and contraindications of SH can lead to excellent functional and anatomical results. It is a patient’s choice whether to accept a higher recurrence rate in order to take the advantage of the short term benefits of SH (121).
Haemorrhoidectomy Vs Ultrasonic-guided Transanal Haemorrhoid Dearterialization
The primary advantage of this procedure is that it is a no cutting technique and as a result it is related to less discomfort and postoperative pain even when it is compared to SH(38) and in less postoperative bleeding resulting in significantly fewer
emergency reoperations than open, stapled, and LigaSure haemorrhoidectomies(121).
However the superiority of the technique is yet to be proven when compared to excisional treatment.
Historically the concept of ligation without excision was associated with a high rate of persistent symptoms but the ligation of the terminal branches of the superior rectal artery may permit long term benefit to the patients. The upcoming results from the literature are confusing with a recent metanalysis of four RCTs(43) comparing the THD procedure with the open haemorrhoidectomy showing that there was not any statistically significant differences between the two techniques regarding the morbidity.
Although a systematic review of seventeen articles including a total of 1996 patients demonstrated that when reported as a function of the haemorrhoidal grade, the recurrence rate was higher for fourth degree haemorrhoids with a range from 11.1- 59.3% (37), the metanalysis of these RCTs failed to demonstrate any statistically significant differences with regard to recurrence and reoperation rates without being able at the same time to determine the efficacy of this technique in advanced
haemorrhoidal disease.
More instruments and a longer postoperative time is required(43) as a disadvantage of the technique compared to excisional treatment but larger high quality, multicentre trials with long term outcomes are needed to prove the benefits of THD and to determine whether is truly necessary or not (43).
Fistula in ano
Advancement Flap and Fistulotomy Vs Fistula Plug
The literature, including two RCTs(122, 123) reports a success rate from 14% (65) to 92% (124). The great variation in results is in part due to variations in patient
selection. Some series have included patients who have had multiple prior attempts at closure and some only first attempts. Some series have had extrusion as a more
frequent complication(57), which is more likely a technical failure or related to postoperative management. The fistula tract length was found to be predictive of a successful closure(125) only later in the literature and in most of the early series of patients it was not accounted. To date there are only four published studies assesing the GORE plug(56, 126-128) and only one which retrospectively compared a series of patients treated with the Surgis with those treated with GORE Bio A(56), where a higher initial clinical success was demonstrated in patients treated with Bio A. The cost, at 500$, for the Gore plug is relatively high, although when compared with endorectal advancement flap it appears to be cost effective(129). This coupled with the low morbidity and the minimal or no effect in stool continence, makes this procedure ideal as a first choice of treatment.
Advancement Flap and Fistulotomy Vs Ligation of the Intersphincteric Fistula Tract
There is one prospective RCT comparing LIFT with advancement flap procedure (130), where LIFT appeared to be simple, safe, shorter with quicker return time to normal activities. Although both had similar recurrence rates, the only patient with minor incontinence belonged to the advancement flap group. In a recent
metanalysis(69) of 24 original articles regarding the LIFT procedure, which included in total 1110 patients with transsphincteric and complex fistula the mean success, incontinence intraoperative and postoperative complication rates were 76.4, 0, 0, 5.5% respectively. There is a recently reported variation of the LIFT procedure,the Bio-LIFT procedure, where a bioprosthetic graft is placed in the intersphincteric plane to reinforce the closure of the fistula tract. The overall healing rate was 94% after a minimum follow up of 12 months with no reported postoperative complications. The experience is still evolving and predictive factors of success are not yet clarified but the preliminary results in the literature support the use of LIFT procedure in complex fistulas with better results when compared to the traditional techniques.
Advancement Flap and Fistulotomy Vs other minimally invasive tecniques
Fibrin Glue
Initial studies on fibrin glue injection for the management of complex anal fistulae were promising (131), as it appeared to be a simple, safe, and painless method and the injections could be repeated to increase the healing rate. In subsequent studies there was a range of success from very low(132) to very high (133, 134). In a pilot study which included patients who were diagnosed with transphincteric anal fistulas of cryptoglandular origin and were treated with fibrin glue after curettage a healing rate of 50% was demonstrated(135). In contrast subsequent studies followed which related the use of fibrin glue with acute anal sepsis(136). Recurrence was associated with
poor irrigation and inadequate preparation of the curreting and the natural course of the secondary disease(137). In further prospective studies that followed, the fibrin glue was mixed with antibiotics but the long term results failed to demonstrate low recurrence rates(138). In randomized studies comparing conventional treatment to fibrin glue technique (139-141), there is a variety of healing rates because of the complexity of the disease and the viability in surgical technique. An important issue with the studies is the length of follow up and it appears that the most failures occur within 6 months (142). Overall, fibrin glue has minimal impact on continence and as it has low morbidity and it does not preclude subsequent treatments can be a good alternative option to conventional treatment(143) but further RCTs are needed to its efficacy as a monotherapy of perianal fistula.
Fistula Laser Closure
The success rate of this procedure is reported in the original article(75) to be 70% and later in two following articles to be 71%(144) and 82%(145) respectively. The reason of failure is that this procedure is a blind procedure , as it is not possible a direct visualization of the fistula tract or any secondary tracts and this may lead to recurrence. It is also an expensive technique as it requires expensive equipment, particularly if compared to other sphincter-sparing techniques. RCTs comparing FiLaC with the most common sphincter-preserving procedures are therefore required.
Video Assisted Anal Fistula Treatment
The overall success rate of this procedure was 73.5% in this initial and only report.
No postoperative incontinence or its worsening is reported(76).
Adipose Derived Stem Cells
In a multicentre, randomized, single blind, add-on clinical trial 200 adult patients from 19 centres were randomly assigned to receive stem cells or stem cells with fibrin glue or fibrin glue alone after closure of the internal opening. There were no
statistically significant differences between the three groups. The healing rates were approximately 40% at 6 months and 50% at 1 year follow up(146). The procedure is considered a safe treatment but the limited available data do not allow safe results in different aspects such as whether this technique is cost effective or not.
Faecal Incontinence
SECCA procedure can be supplementary to a procedure or a treatment that has had less than satisfactory results with improvement in the faecal incontinence scores, without any change in either the measured resting or squeeze pressure. There is a slight decrease on patients’ satisfaction at one year follow up reported in the literature(147). It’s role as a monotherapy is not mentioned in the current literature.
Regarding the SNS, since its first use the clinical efficacy has been confirmed in multiple studies(148). These studies vary regarding outcome criteria but typically the frequency of involuntary loss of bowel content is the measure. There is a lot of research, which has established the low morbidity and complication rate of the temporary wire electrode and its predictive value to a future response in the pe