TROPIS Versus Coring Out Fistulectomy in High Anal Fistula

NCT ID: NCT07334678

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-26
• Study Completion Date: 2026-06-01

Brief Summary

High anal fistulas represent a surgical challenge due to high recurrence rates and risk of postoperative fecal incontinence. Several sphincter-preserving techniques have been developed to address these issues. Coring Out fistulectomy is a traditional sphincter-saving approach, while Transanal Opening of the Intersphincteric Space (TROPIS) is a recently introduced technique with promising outcomes. This randomized clinical trial aims to compare the efficacy, safety, and patient outcomes of TROPIS versus coring out fistulectomy in the management of high complex anal fistulas.

Detailed Description

Fistula-in-ano is an abnormal epithelialized tract connecting the anal canal to the perianal skin, most commonly caused by cryptoglandular infection. High anal fistulas, involving more than one-third of the sphincter complex, carry a significant risk of postoperative incontinence when treated with fistulotomy. As a result, sphincter-preserving techniques have introduced.

Coring out fistulectomy allows excision of the fistulous tract while preserving sphincter integrity but has variable recurrence rates. TROPIS involves transanal opening of the intersphincteric space with complete preservation of the external anal sphincter and has shown high success rates in recent studies.

This prospective randomized clinical trial compares TROPIS and coring out fistulectomy regarding Failure rate (defined as failure of healing or recurrence of anal fistula), operative time, time for wound healing and postoperative complications including fecal incontinence.

Conditions

High Anal Fistula

Study Design

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

Study Groups

Transanal Opening of the Intersphincteric Space (TROPIS)

patient with high anal fistula will be treated with Transanal Opening of the Intersphincteric Space (TROPIS)

Group Type: EXPERIMENTAL

Transanal opening of intersphincteric space (TROPIS)

Intervention Type: PROCEDURE

The fistula tracts on both sides of the External anal sphincter (EAS) are separately dealt with. A curved artery forceps is inserted in the fistula tract in the intersphincteric space through the internal opening.The mucosa and the internal sphincter overlying the artery forceps are then incised with electrocautery. The edges of the resulting wound are trimmed and A gutter is made inferiorly from the opened-up intersphincteric space to the anal verge to facilitate drainage from the intersphincteric space wound in the postoperative period.The fistula tract lateral to (outside) the EAS will be excised till the external anal sphincter.

Coring Out Fistulectomy

patient with high anal fistula will be treated with Coring Out Fistulectomy

Group Type: ACTIVE_COMPARATOR

Coring Out Fistulectomy

Intervention Type: PROCEDURE

Incision was made around external opening.Coring out the fistulous track using a combination of cutting and coagulation diathermy from external opening to internal opening with closure of internal opening

Interventions

Transanal opening of intersphincteric space (TROPIS)

The fistula tracts on both sides of the External anal sphincter (EAS) are separately dealt with. A curved artery forceps is inserted in the fistula tract in the intersphincteric space through the internal opening.The mucosa and the internal sphincter overlying the artery forceps are then incised with electrocautery. The edges of the resulting wound are trimmed and A gutter is made inferiorly from the opened-up intersphincteric space to the anal verge to facilitate drainage from the intersphincteric space wound in the postoperative period.The fistula tract lateral to (outside) the EAS will be excised till the external anal sphincter.

Intervention Type: PROCEDURE

Coring Out Fistulectomy

Incision was made around external opening.Coring out the fistulous track using a combination of cutting and coagulation diathermy from external opening to internal opening with closure of internal opening

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with high anal fistula ( involving more than 1/3 of the sphincter complex), whether de novo or recurrent

Exclusion Criteria

• Patients with fistula secondary to malignancy, inflammatory bowel disease, trauma or radiation
• Patients with Low anal fistula
• Patient with preoperative fecal incontinence
• Previous levator ani muscle injury

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

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mohamed Abdelaal

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haitham M.Azmy Basiouny, Lecturer

Role: STUDY_DIRECTOR

Cairo University

Locations

Faculty of medicine Cairo University

Cairo, Al-Manial Cairo, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed Mohamed Abdelaal, Lecturer

Role: CONTACT

drabdelaal90@gmail.com

+201118732767

Facility Contacts

Ahmed Mohamed Abdelaal, Lecturer

Role: primary

drabdelaal90@gmail.com

+201118732767

Other Identifiers

MS-311-2025

Identifier Type: -

Identifier Source: org_study_id