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

Not Applicable

Completed

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

• Registration Number: NCT06478615
• Lead Sponsor: Ain Shams University

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

Study Timeline

• Study Start: 2022-11-30
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-23
• Study First Submitted QC: 2024-06-23
• Study First Posted: 2024-06-27
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of recurrence of perianal fistula	3 months postoperatively	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt