TROPIS Versus Coring Out Fistulectomy in High Anal Fistula

NCT07334678 | Recruiting

• 1 other identifier: MS-311-2025
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

High Anal Fistula

Keywords

TROPIS; Intersphincteric Space; Coring Out Fistulectomy; High anal fistulas; Sphincter-Preserving Surgery

Outcome Measures

Primary Outcomes (1)

• Compares Failure rate of TROPIS versus Coring Out fistulectomy in high fistula

  Compares Failure rate of TROPIS versus Coring Out fistulectomy in high fistula (failure of healing or recurrence of anal fistula), Early results

  Up to 4 months postoperatively

Secondary Outcomes (9)

• Operative time

  During surgery

• Hospitalization period

  From surgery until discharge

• surgical site infection

  Up to 4 months postoperatively

• Time for wound Healing

  Up to 4 months postoperatively

• Postoperative bleeding

  Up to 4 months postoperatively

Study Arms (2)

Transanal Opening of the Intersphincteric Space (TROPIS)

EXPERIMENTAL

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

Procedure: Transanal opening of intersphincteric space (TROPIS)

Coring Out Fistulectomy

ACTIVE COMPARATOR

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

Procedure: Coring Out Fistulectomy

Interventions

Transanal opening of intersphincteric space (TROPIS) 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.

Transanal Opening of the Intersphincteric Space (TROPIS)

Coring Out Fistulectomy 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

Coring Out Fistulectomy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of medicine Cairo University

Cairo, Al-Manial Cairo, 11451, Egypt

RECRUITING

Study Officials

• Haitham M.Azmy Basiouny, Lecturer

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Ahmed Mohamed Abdelaal, Lecturer

CONTACT

+201118732767; drabdelaal90@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: January 12, 2026
• Study Start: July 8, 2025
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: May 27, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)