TROPIS Versus Coring Out Fistulectomy in High Anal Fistula
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transanal opening of intersphincteric space (TROPIS), Coring Out Fistulectomy.
- Who it may be relevant to
- Registry conditions: High Anal Fistula. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Interventions
- Procedure 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 intersphincte - 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
Primary outcome measures
- Compares Failure rate of TROPIS versus Coring Out fistulectomy in high fistula [Time frame: Up to 4 months postoperatively]
Secondary outcome measures (9)
- Operative time [Time frame: During surgery]
- Hospitalization period [Time frame: From surgery until discharge]
- surgical site infection [Time frame: Up to 4 months postoperatively]
- Time for wound Healing [Time frame: Up to 4 months postoperatively]
- Postoperative bleeding [Time frame: Up to 4 months postoperatively]
- postoperative fecal incontinence [Time frame: Up to 4 months postoperatively]
- Time to return to normal activity [Time frame: Up to 4 months postoperatively]
- Postoperative urine retention [Time frame: Within 48 hours postoperatively]
- Pain intensity [Time frame: At day 1 and day 7 postoperatively]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of medicine Cairo University — Cairo
Identifiers
NCT: NCT07334678 · MS-311-2025