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

NCT06478615 | Completed

• 1 other identifier: 30/10/2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of recurrence of perianal fistula

  Incidence of recurrence of perianal fistula was recorded and confirmed when an anal fistula or abscess is observed on any previously healed wound for 3 months.

  3 months postoperatively

Secondary Outcomes (4)

• Incidence of stool incontinence

  3 months postoperatively

• Healing time

  3 months postoperatively

• Length of hospital stay

  1 week postoperatively

• Complications

  3 months postoperatively

Study Arms (2)

Coring out Fistulectomy with Closure of Internal Sphincter Opening

EXPERIMENTAL

Patients underwent coring out fistulectomy with closure of internal sphincter opening

Procedure: Coring out Fistulectomy with Closure of Internal Sphincter Opening

Lay Open Fistulotomy and Primary Sphincter Repair

EXPERIMENTAL

Patients underwent lay open fistulotomy and primary sphincter repair

Procedure: Lay Open Fistulotomy and Primary Sphincter Repair

Interventions

Coring out Fistulectomy with Closure of Internal Sphincter Opening 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.

Coring out Fistulectomy with Closure of Internal Sphincter Opening

Lay Open Fistulotomy and Primary Sphincter Repair 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.

Lay Open Fistulotomy and Primary Sphincter Repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of General Surgery, Faculty of Medicine, Ain Shams University, Egypt

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: June 27, 2024
• Study Start: November 30, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)