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

Coring Out Fistulectomy With Closure of Internal Sphincter Opening Versus Lay Open Fistulotomy and Primary Sphincter Repair in Transsphincteric Perianal Fistula; A Prospective Randomized Comparative Study

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

Study Overview

• Status: Completed
• Conditions: Internal Sphincter; Lay Open Fistulotomy; Sphincter Repair; Transsphincteric Perianal Fistula; Coring Out; Fistulectomy
• Intervention / Treatment: Procedure: Coring out Fistulectomy with Closure of Internal Sphincter Opening; Procedure: Lay Open Fistulotomy and Primary Sphincter Repair

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coring out Fistulectomy with Closure of Internal Sphincter Opening; Patients underwent coring out fistulectomy with closure of internal sphincter opening	Procedure: 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.
Experimental: Lay Open Fistulotomy and Primary Sphincter Repair; Patients underwent lay open fistulotomy and primary sphincter repair	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of stool incontinence	Incidence of stool incontinence was recorded for 3 months.	3 months postoperatively
Healing time	Healing was defined as cicatrization of all wounds without discharge at 3 months	3 months postoperatively
Length of hospital stay	Length of hospital stay was recorded from admission till discharge from hospital.	1 week postoperatively
Complications	Complications such as (blood loss, pain, bleeding, discharge, urinary retention, urgency, wound infection) were recorded.	3 months postoperatively

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: June 23, 2024
• First Submitted That Met QC Criteria: June 23, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Rectal Fistula
• Other Study ID Numbers: 30/10/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No