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

Not Applicable

• Conditions: Anal Fistula
• Interventions: Procedure: Seton; Procedure: Parks; Procedure: LIFT

• Registration Number: NCT04377542
• Lead Sponsor: Mansoura University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-12-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-01
• Study First Submitted QC: 2020-05-05
• Last Update Submitted: 2020-05-05
• Study First Posted: 2020-05-06
• Last Update Posted: 2020-05-06
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Seton	Seton	Two-stage seton placement
Parks	Parks	Modified Parks technique
LIFT	LIFT	Ligation of intersphincteric fistula tract

Primary Outcome Measures

Name	Time	Method
Healing of anal fistula	6 months after surgery	complete epithelization of the surgical wound was ascertained, the external and the internal openings were closed, and no discharge was experienced.

Trial Locations

Locations (1)

Mansoura university hospital; 🇪🇬 Mansourah, Dakahlia, Egypt