Coring Out Fistulectomy With Closure of Internal Sphincter Opening Versus Lay Open Fistulotomy and Primary Sphincter Repair in Transsphincteric Perianal Fistula

NCT ID: NCT06478615

Last Updated: 2024-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-30
• Study Completion Date: 2024-03-01

Brief Summary

This study aimed to compare the surgical outcomes of coring out fistulectomy with the closure of internal sphincter opening versus lay open fistulotomy (modified LIFT) and lay open fistulotomy and primary sphincter repair in trans-sphincteric perianal fistula

Detailed Description

Fistula-in-ano is a common medical problem affecting thousands of patients annually. Symptoms generally affect quality of life significantly, and they range from minor discomfort and drainage with resultant hygienic problems to sepsis. Different classifications have been put forward which categorize these Fistula into low or high simple or complex, or according to their anatomy inter-sphincteric, trans-sphincteric, and supra- sphincteric or extra-sphincteric.

Conventional laying-open technique in high perianal fistula may involve sacrifice of part or whole of the sphincter muscle impairing continence. A transposition technique for the management of high anal and anorectal fistulae is described by Mann and Clifton in 1985. The method involves re-routing the extrasphincteric portion of the track into an intersphincteric position with immediate repair of the external sphincter.

Coring-out fistulectomy is a type of sphincter-preserving procedure that enables accurate resection of the fistula tract alone and thus reduces the possibility of missing a secondary tract

Conditions

Coring Out; Fistulectomy; Internal Sphincter; Lay Open Fistulotomy; Sphincter Repair; Transsphincteric Perianal Fistula

Study Design

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

Study Groups

Coring out Fistulectomy with Closure of Internal Sphincter Opening

Patients underwent coring out fistulectomy with closure of internal sphincter opening

Group Type: EXPERIMENTAL

Coring out Fistulectomy with Closure of Internal Sphincter Opening

Intervention Type: PROCEDURE

The patient was laid in the lithotomy position. Skin preparation and draping were done. Normal saline irrigation was performed. The anal canal was sufficiently dilated to permit the introduction of a self-retaining retractor. With H2O2 injection into the fistula tract, the internal opening and tract of the fistula will be identified. The incision was made around the external opening, and the tract was all cored out along the tract from the external opening to the internal sphincter. Meticulous hemostasis will be performed, stay suture by PDS 4/0 around fistiolous opening at the internal sphincter, excision of fistulous tract above stay suture, then closure of internal sphincter defect by PDS 3/0. Anal packing with 4 × 4 epinephrine gauze and sterile protective dressing was performed. After the operation, a stool softener and pain controller were prescribed, and patients were discharged.

Lay Open Fistulotomy and Primary Sphincter Repair

Patients underwent lay open fistulotomy and primary sphincter repair

Group Type: EXPERIMENTAL

Lay Open Fistulotomy and Primary Sphincter Repair

Intervention Type: PROCEDURE

Patients were put in a lithotomy position and the skin was then draped. After identification of the external fistula orifice probing of the fistula tract with identification of the fistulous tract and internal orifice with H2O2 injection into the fistula tract. The fistula was laid open and fistulectomy was then conducted and dissected with diathermy cautery help. Then Primary repair of the sphincter with PDS 3/0 with proper hemostasis using coagulation diathermy.

Interventions

Coring out Fistulectomy with Closure of Internal Sphincter Opening

The patient was laid in the lithotomy position. Skin preparation and draping were done. Normal saline irrigation was performed. The anal canal was sufficiently dilated to permit the introduction of a self-retaining retractor. With H2O2 injection into the fistula tract, the internal opening and tract of the fistula will be identified. The incision was made around the external opening, and the tract was all cored out along the tract from the external opening to the internal sphincter. Meticulous hemostasis will be performed, stay suture by PDS 4/0 around fistiolous opening at the internal sphincter, excision of fistulous tract above stay suture, then closure of internal sphincter defect by PDS 3/0. Anal packing with 4 × 4 epinephrine gauze and sterile protective dressing was performed. After the operation, a stool softener and pain controller were prescribed, and patients were discharged.

Intervention Type: PROCEDURE

Lay Open Fistulotomy and Primary Sphincter Repair

Patients were put in a lithotomy position and the skin was then draped. After identification of the external fistula orifice probing of the fistula tract with identification of the fistulous tract and internal orifice with H2O2 injection into the fistula tract. The fistula was laid open and fistulectomy was then conducted and dissected with diathermy cautery help. Then Primary repair of the sphincter with PDS 3/0 with proper hemostasis using coagulation diathermy.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age more than 18 years old.
• Both sexes.
• American Society of Anesthesiology (ASA) physical status I, II.
• Fistula in ano, Trans-sphincteric type

Exclusion Criteria

• Patients with low perianal fistula.
• Recurrent perianal fistula.
• Associated anal conditions such as (piles, anal fissures, and rectal prolapse).
• Patients with inflammatory bowel disease or tuberculosis.
• Patients with acute perianal abscess.
• Patients with major incontinence.

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

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Ibrahim Ali Ahmed

Assistant Lecturer of General Surgery, Faculty of Medicine, Ain Shams University, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

30/10/2022

Identifier Type: -

Identifier Source: org_study_id