Clinical trial NCT03311035: LIFT Technique Versus Seton in Management of Anal Fistula
Official title: LIFT Technique Versus Seton in Management of Anal Fistula
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anal Fistula
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-10-16
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be classified into two groups according to the surgical procedure performed as follows:

* Group A: Patients undergoing cutting Seton.
* Group B: Patients undergoing LIFT technique
Primary purpose: TREATMENT

Brief summary: Abscesses and anal fistulas represent about 70% of perianal suppuration, with an estimated incidence of 1/10,000 inhabitants per year and representing 5% of queries in coloproctology.

Anal fistula is the chronic phase of anorectal infection is characterized by chronic purulent drainage or cyclic pain associated with acute relapse of the abscess followed by intermittent spontaneous decompression.

Perianal fistulas have a troublesome pathology. The most widely accepted theory is that anal abscess is caused by infection of an anal crypt gland. Suppuration moves from the anal gland to the inter-sphincteric space, forming an abscess leading to the development of a fistula. The incidence of fistula following an abscess is nearly 33%.

A fistula can cause pain, perianal swelling, discharge, bleeding, and other nonspecific symptoms.

The diagnosis of fistula-in-ano may include a digital rectal examination, endoanal ultrasound, fistulography, and MRI.

The management of the disease is difficult and sometimes a challenge for the surgeon.

The ideal treatment is based on three central principles: control of sepsis, closure of the fistula and maintenance of continence.

The management of complex fistulas needs to balance the outcomes of cure and continence. Success is usually determined by identification of the primary opening and dividing the least amount of muscle as possible.

There is a risk of sphincter muscle damage during fistulotomy, which can lead to an unacceptable risk of anal incontinence of varying degrees.

The surgical techniques described for the treatment of fistula-in-ano are fistulotomy, core-out fistulectomy, seton placement, endorectal advancement flap, injection of fibrin glue, insertion of a fistula plug, video-assisted anal fistula treatment (VAAFT) and ligation of the intersphincteric fistula tract (LIFT), Surgical techniques are composed of 2 broad categories, including sphincter sacrificing procedures, such as, fistulotomy, fistulectomy and cutting seton. and sphincter-preserving procedures, such as fibrin glue injection, fistula plug, rectal advancement flap, VAAFT and LIFT. In general, sphincter sacrificing procedures have high success rates but are associated with high rates of fecal incontinence. In contrast, sphincter-preserving procedures have more modest success rates but are associated with a relatively minimal risk of changes in continence.

While low transsphincteric fistulae are well-addressed by fistulotomy (i.e., lay-open technique) with minimal change in long-term bowel habits, fistulae which involve more than 30 % of the internal sphincter carry a substantial risk of fecal incontinence with this approach.

Endorectal advancement flap is technically difficult and associated with high recurrence rate up to 50% and risk of incontinence up to 35%.

Fibrin glue and anal fistula plug have a little effect on incontinence but are associated with high recurrence up to 60 % and are costive.

VAAFT is effective method but is highly costive.

Setons can be employed as cutting and non-cutting kinds as dividers or markers . A few types of setons used are the Ayurveda-medicated thread , braided sutures thread, rubber band , Penrose drains and cable tie seton . Seton material should be non-absorbable, from non-slippage material, comfortable and least irritant for the patient and equally ejective in causing focal reaction in the track, leading to fibrosis .

However, setons may cause patient discomfort, both from irritation and from persistent drainage. In addition the incontinence rate may reach 67%.

The ligation of intersphincteric fistula tract (LIFT) was first described by Rojanasakul and colleagues in 2007. Since then, this technique has become popular among providers due to its simple technical elements, particularly when compared to anorectal advancement flaps, and favorable success rate. Among the many studies published in the literature, the success rate after LIFT ranges from 40 to 95 %, with a recurrence rate of 6-28 % .3,5-28 In comparison, success after advancement flap ranges from 60 to 94 %.

Detailed description: This study is a prospective study;

B) Methodology:

Patients will be classified into two groups according to the surgical procedure performed as follows:

* Group A: Patients undergoing cutting Seton.
* Group B: Patients undergoing LIFT technique.

Aim OF THE STUDY:

To compare between Seton and LIFT technique in management of anal fistula according to ;

1-Feasibility of the technique. 3-Postoperative pain and use of analgesia. 4-Healing time. 5-Recurrence rate. 6-Occurrence of fecal incontinence.

Eligibility criteria: Inclusion Criteria:

* All patients who will undergo LIFT technique and Seton for management of anal fistula at General surgery department - Assiut University

Exclusion Criteria:

* patients under age of 16 years old.
* patients with malignant fistula.
* patients with crohn's disease.
* patients with Tuberculosis.
* patients with intersphincteric fistula. Patients with anal fistula and anal incontinence

Primary outcomes:
measure: Recurrence of the fistula
timeFrame: Up to one year from last case
Secondary outcomes:
measure: Postoperative pain
timeFrame: up to 2 weeks postoperatively for each case
measure: Fecal Incontinence
timeFrame: up to 2 months postoperatively for each case
measure: Healing time of the wound
timeFrame: up to 3 months postoperatively for each case
Other outcomes:
Locations:
Study officials:
References:
citation: Dudukgian H, Abcarian H. Why do we have so much trouble treating anal fistula? World J Gastroenterol. 2011 Jul 28;17(28):3292-6. doi: 10.3748/wjg.v17.i28.3292.
citation: Xu Y, Tang W. Ligation of Intersphincteric Fistula Tract Is Suitable for Recurrent Anal Fistulas from Follow-Up of 16 Months. Biomed Res Int. 2017;2017:3152424. doi: 10.1155/2017/3152424. Epub 2017 Feb 8.
citation: Chen HJ, Sun GD, Zhu P, Zhou ZL, Chen YG, Yang BL. Effective and long-term outcome following ligation of the intersphincteric fistula tract (LIFT) for transsphincteric fistula. Int J Colorectal Dis. 2017 Apr;32(4):583-585. doi: 10.1007/s00384-016-2723-2. Epub 2016 Nov 23.
citation: Khadia M, Muduli IC, Das SK, Mallick SN, Bag L, Pati MR. Management of Fistula-In-Ano with Special Reference to Ligation of Intersphincteric Fistula Tract. Niger J Surg. 2016 Jan-Jun;22(1):1-4. doi: 10.4103/1117-6806.169818.
citation: Mushaya C, Bartlett L, Schulze B, Ho YH. Ligation of intersphincteric fistula tract compared with advancement flap for complex anorectal fistulas requiring initial seton drainage. Am J Surg. 2012 Sep;204(3):283-9. doi: 10.1016/j.amjsurg.2011.10.025. Epub 2012 May 19.
citation: Charua-Guindic L, Mendez-Moran MA, Avendano-Espinosa O, Jimenez-Bobadilla B, Charua-Levy E. [Complex anal fistula treated with cutting seton]. Cir Cir. 2007 Sep-Oct;75(5):351-6. Spanish.
citation: Ye F, Tang C, Wang D, Zheng S. Early experience with the modificated approach of ligation of the intersphincteric fistula tract for high transsphincteric fistula. World J Surg. 2015 Apr;39(4):1059-65. doi: 10.1007/s00268-014-2888-1.
citation: Zirak-Schmidt S, Perdawood SK. Management of anal fistula by ligation of the intersphincteric fistula tract - a systematic review. Dan Med J. 2014 Dec;61(12):A4977.