An interventional study of Transanal opening of intersphincteric space (TROPIS) and Coring Out Fistulectomy in High Anal Fistula, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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.
Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patient with high anal fistula will be treated with Transanal Opening of the Intersphincteric Space (TROPIS)
Procedure: Transanal opening of intersphincteric space (TROPIS)
patient with high anal fistula will be treated with Coring Out Fistulectomy
Procedure: Coring Out Fistulectomy
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.
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
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
Time frame: Up to 4 months postoperatively
Operative time
compare time of operation between both procedure
Time frame: During surgery
Hospitalization period
compare how many days patients stay in hospital postoperatively in both groups
Time frame: From surgery until discharge
surgical site infection
compare surgical site infection in both groups
Time frame: Up to 4 months postoperatively
Time for wound Healing
Time for wound Healing in both groups
Time frame: Up to 4 months postoperatively
Postoperative bleeding
compare Postoperative bleeding in both groups
Time frame: Up to 4 months postoperatively
postoperative fecal incontinence
compare post postoperative fecal incontinence in both groups
Time frame: Up to 4 months postoperatively
Time to return to normal activity
Compare Time to return to normal activity in both groups
Time frame: Up to 4 months postoperatively
Postoperative urine retention
compare postoperative urine retention in both groups
Time frame: Within 48 hours postoperatively
Pain intensity
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}).
Time frame: At day 1 and day 7 postoperatively
Plan to share: No — Individual participant data (IPD) will not be shared because this is a small surgical trial with a limited number of participants, and sharing raw data could lead to identification of participants
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Cairo University