None listed
Conditions
Brief summary
Low transsphincteric fistulas comprising less than 1/3 of the external sphincter complex are easy to treat by fistulotomy with a high success rate. High transsphincteric fistulas remain a surgical challenge. Surgical procedures include advancement flaps, loose-seton placement, fistula plug and the installation of fibrin glue Usually, less invasive approaches do not jeopardize continence, but healing rates can be very low. Nowadays, flap repair remains the ‘gold standard’ for the treatment of high trans-sphincteric perianal or complex fistulas even though a recurrence rate of approximately 30% can be commonly observed, leaving much room for improvement [1-6]. Recently, a novel sphincter-saving technique consisting of ligation of the intersphincteric tract (LIFT) has been added to the armamentarium for the management of ‘complex’ anal fistulas. The initial report in 2006 from Rojanasakul et al. [7] showed a 94% healing rate with a 3-month follow-up. Since then, only a few studies of the use of this technique have been reported with variable success rates from 57 to 89%. (8,9). Also platelet rich plasma slowly releases growth factors that help in wound healing and was proved to be successful in management of some cases of fistula-in ano These results call for a prospective randomised controlled trial. Since mucosal flap advancement is the preferred treatment for high cryptoglandular perianal fistula, the anal fistula LIFT will be compared with both LIFT and platelet rich plasma injection and mucosal flap advancement in a randomised setting. References 1. Sainio P: Fistula-in-ano in a defined population. Incidence and epidemiological aspects. Ann Chir Gynaecol 1984, 73(4):219-24. 2. Marks CG, Ritchie JK: Anal fistulas at St Mark's Hospital. Br J Surg 1977, 64(2):84-91. 3. Parks AG: Pathogenesis and treatment of fistula-in-ano. Br Med J 1961, 1(5224):463-9. 4. Parks AG, Gordon PH, Hardcastle JD: A classification of fistula-inano. Br J Surg 1976, 63(1):1-12. 5. Ortiz H, Marzo J: Endorectal flap advancement repair and fistulectomy for high trans-sphincteric and suprasphincteric fistulas. Br J Surg 2000, 87(12):1680-3. 6. Sileri P, Franceschilli L, Del Vecchio Blanco G, Stolfi VM, Angelucci GP, Gaspari AL (2011) Porcine dermal collagen matrix injection may enhance flap repair surgery for complex anal fistula. Int J Colorectal Dis 26:345–349 7. Rojanasakul A, Pattanaarun J, Sahakitrungruang C, Tantiphlachiva K (2007) Total anal sphincter saving technique for fistulain- ano: the ligation of intersphincteric fistula tract. J Med Assoc Thai 90:581–586 8. Shanwani A, Nor AM, Amri N (2010) Ligation of intersphincteric fistula tract (LIFT): a sphincter-saving technique in fistulain- ano. Dis Colon Rectum 53:39–43 9. Bleier JI, Moloo H, Goldberg SM (2010) Ligation of the intersphincteric fistula tract: an effective new technique for complex fistulas. Dis Colon Rectum 53:43–46
Interventions
All procedures will be performed under general or locoregional anaesthesia. Approximate duration is about 60-90 minutes. Prophylactic broad-spectrum antibiotics will be administered before surgery. During surgery the internal fistula tract opening will be identified. For LIFT: a probe is inserted into the external opening exiting through the internal opening. The intersphincteric groove is then identified, and a small circumanal incision (2 cm) overlying the fistula tract is made to enter the sp
All procedures will be performed under general or locoregional anaesthesia. Approximate duration is about 60-90 minutes. Prophylactic broad-spectrum antibiotics will be administered before surgery. During surgery the internal fistula tract opening will be identified. For LIFT: a probe is inserted into the external opening exiting through the internal opening. The intersphincteric groove is then identified, and a small circumanal incision (2 cm) overlying the fistula tract is made to enter the space between the internal and external sphincters. Diathermy and blunt dissection is used to dissect the intersphincteric plane and reach the probed fistula tract. The dissection is kept as close as possible to the internal anal sphincter (IAS), and two small retractors were used to open the space, gently separating the sphincters. The fistula tract is then encircled using a right-angle clamp, and two absorbable sutures (3-0 vicryl) were used to doubly secure and close the fistula tract as close as possible to the lateral margin of IAS and the medial margin of the external anal sphincter (EAS). At this point, the tract between these two sutures is divided, excised for few millimetres and sent for pathologic examination. In order to confirm the closure of both the internal and external fistula tract, H2O2 was injected from the internal and the external orifices. The intersphincteric plane is then irrigated with H2O2 and saline, checked for haemostasis and closed in two layers (muscle approximation and skin) using interrupted 3-0 vicryl. The external and internal orifices are left open to allow drainage. Antibiotic prophylaxis consists of second-generation cephalosporin and metronidazole for 5 days after surgery.
Sponsors
khaled madbouly
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria are; age above 18 years, high anorectal fistula of cryptoglandular origin (transsphincteric, upper 2/3 of the sphinctercomplex which is confined by the puborectal sling and the end of the anal canal), and informed consent.
Exclusion criteria
Exclusion criteria are; no internal opening found during surgery, HIV-positive patients, Crohn's disease, malignant cause, tuberculosis, hydradenitis suppurativa, and pilonidal sinus disease.
Outcome results
None listed