RecruitingACTRN12612000819820

The Anal Fistula ligation of the intersphincteric tract (LIFT) with or without local injection of platelet rich plasma versus mucosal advancement flap for treatment of transsphincteric anal fistula

Comparison of healing, recurrence and quality of life between Anal Fistula ligation of the intersphincteric tract (LIFT)with or without local injection of platelet rich plasma and mucosal advancement flap for treatment of transsphincteric anal fistula in adults


Sponsor

khaled madbouly

Enrollment

116 participants

Start Date

Jan 2, 2013

Study Type

Interventional

Conditions

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


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares three surgical techniques for treating a high anal fistula (an abnormal tunnel between the inside of the bowel and the skin near the anus). High anal fistulas are difficult to treat without risking bowel control. The three approaches tested are: ligation of the tract (LIFT), LIFT with platelet-rich plasma injection to help healing, and a tissue flap procedure. The goal is to find which method has the best cure rate while preserving bowel control. You may be eligible if: - You are 18 to 75 years old - You have a high anal fistula (through the upper two-thirds of the sphincter muscle) of cryptoglandular origin (not caused by Crohn's disease or infection) - You have given informed consent You may NOT be eligible if: - No internal opening can be found during surgery - You are HIV-positive - You have Crohn's disease, cancer, tuberculosis, or hidradenitis suppurativa - Your fistula is caused by a pilonidal sinus Talk to your doctor about whether this trial might be right for you.

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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. Du

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.


Locations(1)

Egypt

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ACTRN12612000819820