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NCT Number: NCT07334678

TROPIS Versus Coring Out Fistulectomy in High Anal Fistula

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.

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Key information

Conditions

High Anal Fistula

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine Cairo University

Cairo, Al-Manial Cairo, 11451, Egypt

Location status: Recruiting

Location contact

Ahmed Mohamed Abdelaal, Lecturer

CONTACT

[email protected]

+201118732767

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

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

    Time frame: Up to 4 months postoperatively

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

Secondary outcomes

  1. Operative time

    Time frame: During surgery

    compare time of operation between both procedure

  2. Hospitalization period

    Time frame: From surgery until discharge

    compare how many days patients stay in hospital postoperatively in both groups

  3. surgical site infection

    Time frame: Up to 4 months postoperatively

    compare surgical site infection in both groups

  4. Time for wound Healing

    Time frame: Up to 4 months postoperatively

    Time for wound Healing in both groups

  5. Postoperative bleeding

    Time frame: Up to 4 months postoperatively

    compare Postoperative bleeding in both groups

  6. postoperative fecal incontinence

    Time frame: Up to 4 months postoperatively

    compare post postoperative fecal incontinence in both groups

  7. Time to return to normal activity

    Time frame: Up to 4 months postoperatively

    Compare Time to return to normal activity in both groups

  8. Postoperative urine retention

    Time frame: Within 48 hours postoperatively

    compare postoperative urine retention in both groups

  9. Pain intensity

    Time frame: At day 1 and day 7 postoperatively

    Compare Pain intensity measured using Visual Analogue Scale between both groups (Visual Analogue Scale for Pain: ranges from 0 to 10 . Higher scores indicate a worse outcome {greater pain intensity}).

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Mohamed Abdelaal, Lecturer

CONTACT

[email protected]

+201118732767

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: TROCO-HAF

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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