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

NCT ID: NCT04377542

Last Updated: 2020-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-06-30

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.

Conditions

Anal Fistula

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LIFT

Ligation of intersphincteric fistula tract

Group Type: ACTIVE_COMPARATOR

LIFT

Intervention Type: PROCEDURE

Ligation of the fistula tract in the intersphincteric plane

Parks

Modified Parks technique

Group Type: ACTIVE_COMPARATOR

Parks

Intervention Type: PROCEDURE

Modified Parks fistulotomy with complete internal anal sphincterotomy

Seton

Two-stage seton placement

Group Type: ACTIVE_COMPARATOR

Seton

Intervention Type: PROCEDURE

Excision of the superficial part of fistula tract and tying loose seton around the remaining part and anal sphincter muscles

Interventions

LIFT

Ligation of the fistula tract in the intersphincteric plane

Intervention Type: PROCEDURE

Parks

Modified Parks fistulotomy with complete internal anal sphincterotomy

Intervention Type: PROCEDURE

Seton

Excision of the superficial part of fistula tract and tying loose seton around the remaining part and anal sphincter muscles

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sameh H Emile, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

Mansoura152020

Identifier Type: -

Identifier Source: org_study_id