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TROPIS Versus Coring Out Fistulectomy in High Anal Fistula

ConditionHigh Anal Fistula
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transanal opening of intersphincteric space (TROPIS)

    Procedure/Surgery

    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/Surgery

    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

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Transanal Opening of the Intersphincteric Space (TROPIS)Experimental treatment 1 intervention
Group B: Coring Out FistulectomyActive comparator 1 intervention

Trial outcomes

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

Time frame
Up to 4 months postoperatively

Secondary outcomes

1

Operative time

compare time of operation between both procedure

Time frame
During surgery
2

Hospitalization period

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

Time frame
From surgery until discharge
3

surgical site infection

compare surgical site infection in both groups

Time frame
Up to 4 months postoperatively
4

Time for wound Healing

Time for wound Healing in both groups

Time frame
Up to 4 months postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov
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