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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transanal Opening of the Intersphincteric Space (TROPIS) | Experimental | patient with high anal fistula will be treated with Transanal Opening of the Intersphincteric Space (TROPIS) |
|
| Coring Out Fistulectomy | Active Comparator | patient with high anal fistula will be treated with Coring Out Fistulectomy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 4 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | compare time of operation between both procedure | During surgery |
| Hospitalization period | compare how many days patients stay in hospital postoperatively in both groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Mohamed Abdelaal, Lecturer | Contact | +201118732767 | drabdelaal90@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Haitham M.Azmy Basiouny, Lecturer | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine Cairo University | Recruiting | Cairo | Al-Manial Cairo | 11451 | Egypt |
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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| 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 |
|
| From surgery until discharge |
| surgical site infection | compare surgical site infection in both groups | Up to 4 months postoperatively |
| Time for wound Healing | Time for wound Healing in both groups | Up to 4 months postoperatively |
| Postoperative bleeding | compare Postoperative bleeding in both groups | Up to 4 months postoperatively |
| postoperative fecal incontinence | compare post postoperative fecal incontinence in both groups | Up to 4 months postoperatively |
| Time to return to normal activity | Compare Time to return to normal activity in both groups | Up to 4 months postoperatively |
| Postoperative urine retention | compare postoperative urine retention in both groups | 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}). | At day 1 and day 7 postoperatively |