RecruitingNot ApplicableNCT07334678

TROPIS Versus Coring Out Fistulectomy in High Anal Fistula

Early Results of Transanal Opening of the Intersphincteric Space (TROPIS) Versus Coring Out Fistulectomy in Management of High Anal Fistulas: A Randomized Clinical Trial

Sponsor

Cairo University

Enrollment

64 participants

Start Date

Nov 26, 2025

Study Type

INTERVENTIONAL

Conditions

High Anal Fistula

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria1

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

Exclusion Criteria4

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

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Interventions

PROCEDURETransanal 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.

PROCEDURECoring 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

Locations(1)

Faculty of medicine Cairo University

Cairo, Al-Manial Cairo, Egypt

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NCT07334678