High Anal Fistula
Conditions
Keywords
TROPIS, Intersphincteric Space, Coring Out Fistulectomy, High anal fistulas, Sphincter-Preserving Surgery
Brief summary
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
PROCEDURETransanal 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 intersphincteric space wound in the postoperative period.The fistula tract lateral to (outside) the EAS will be excised till the external anal sphincter.
PROCEDURECoring 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
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compares Failure rate of TROPIS versus Coring Out fistulectomy in high fistula | 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
| Measure | Time frame | Description |
|---|---|---|
| Operative time | During surgery | compare time of operation between both procedure |
| Hospitalization period | From surgery until discharge | compare how many days patients stay in hospital postoperatively in both groups |
| surgical site infection | Up to 4 months postoperatively | compare surgical site infection in both groups |
| Time for wound Healing | Up to 4 months postoperatively | Time for wound Healing in both groups |
| Postoperative bleeding | Up to 4 months postoperatively | compare Postoperative bleeding in both groups |
| postoperative fecal incontinence | Up to 4 months postoperatively | compare post postoperative fecal incontinence in both groups |
| Time to return to normal activity | Up to 4 months postoperatively | Compare Time to return to normal activity in both groups |
| Postoperative urine retention | Within 48 hours postoperatively | compare postoperative urine retention in both groups |
| Pain intensity | 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}). |
Countries
Egypt
Contacts
CONTACTAhmed Mohamed Abdelaal, Lecturer
STUDY_DIRECTORHaitham M.Azmy Basiouny, Lecturer
Cairo University
Outcome results
None listed