TROPIS Versus Coring Out Fistulectomy in High Anal Fistula (TROCO-HAF)

Cairo University (CU)

Status: Enrolling

Conditions: High Anal Fistula

Treatments: Procedure: Coring Out Fistulectomy; Procedure: Transanal opening of intersphincteric space (TROPIS)

Study type: Interventional

Funder types: Other

Identifiers

NCT07334678

MS-311-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Transanal Opening of the Intersphincteric Space (TROPIS)

Experimental group

Description:

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

Treatment:

Procedure: Transanal opening of intersphincteric space (TROPIS)

Coring Out Fistulectomy

Active Comparator group

Description:

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

Treatment:

Procedure: Coring Out Fistulectomy