RCT on LIFT Versus Modified Parks Technique Versus Two-Stage Seton

Study Overview
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Brief Summary
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LIFT is a sphincter-saving procedure that is based on the concept of secure closure of the internal opening and concomitant removal of infected cryptoglandular tissue in the intersphincteric plane. Modified Parks technique involves adequate drainage of the intersphincteric space by extending the internal anal sphincterotomy. Placement of seton in the fistula track has been used for a long time and is still being currently used. Drainage two-stage seton is used to promote adequate drainage of infection and can be employed as a definitive treatment of anal fistula. This present randomized study aimed to compare LIFT, modified Parks technique, and two-stage seton in treatment of complex anal fistula in terms of success of treatment and complication rates.

Official Title
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Randomized Controlled Trial on Ligation of Intersphincteric Fistula Tract (LIFT) Versus Modified Parks Technique Versus Two-Stage Seton In Treatment of Complex Anal Fistula

Conditions
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Anal Fistula

Intervention / Treatment
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* Procedure: LIFT
* Procedure: Parks
* Procedure: Seton


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult Patients of either sex aged less than 65 years presenting with complex anal fistula were included. Complex anal fistulas were defined as high trans-sphincteric (involving more than 30% of the external anal sphincter), extra-sphincteric, supra-sphincteric, horse-shoe fistulas and anterior fistulas in females Exclusion Criteria: Patients with simple anal fistula (intersphincteric and low trans-sphincteric anal fistula) Patients with associated anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases. Patients on long-acting steroids or immunosuppressive drugs. Patients with fecal incontinence (FI) Patients with previous anorectal operations including surgery for previous anal fistula. Patients with ASA score (American society of anesthesiologists) of III and higher

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LIFT<br>Ligation of intersphincteric fistula tract | Procedure: LIFT<br>* Ligation of the fistula tract in the intersphincteric plane<br>|
| Active Comparator: Parks<br>Modified Parks technique | Procedure: Parks<br>* Modified Parks fistulotomy with complete internal anal sphincterotomy<br>|
| Active Comparator: Seton<br>Two-stage seton placement | Procedure: Seton<br>* Excision of the superficial part of fistula tract and tying loose seton around the remaining part and anal sphincter muscles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing of anal fistula | complete epithelization of the surgical wound was ascertained, the external and the internal openings were closed, and no discharge was experienced. | 6 months after surgery |