Clinical trial · Interventional
Drainage Seton With Flap Versus EAS Preserving Seton in Treatment of Transsphincteric Anal Fistula
Drainage Seton Around the External Anal Sphincter With Mucosal Advancement Flap Versus External Anal Sphincter Preserving Seton in Treatment of Trans-sphincteric Anal Fistula
NCT03983174CI-TRIAL-00039116completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients with high trans-sphincteric anal fistula will be randomized to one of two equal group: group 1 will have drainage seton with mucosal advancement flap and group 2 will undergo external anal sphincter sparing seton
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drainage seton with flap | Procedure | — | UNRESOLVED |
| EAS sparing seton | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Drainage seton with flap
- description
- Drainage seton will be put around the external anal sphincter with mucosal advancement flap
- interventionNames
- Procedure: Drainage seton with flap
- type
- EXPERIMENTAL
- label
- EAS sparing seton
- description
- Rerouting of the seton around the internal anal sphincter sparing the external sphincter will be done
- interventionNames
- Procedure: EAS sparing seton
Primary outcomes (1)
- measure
- fecal incontinence
- timeFrame
- 12 months after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients suffering from high trans-sphincteric anal fistula Exclusion Criteria: * Acute sepsis. * Specific cause of fistula e.g. Crohn's disease * Strictured anorectum. * Any degree of incontinence * Recurrent anal fistula. * Low anal fistula. * Previous anorectal surgery.
References
Publications (0)
Data not yet available
No reference posted for this study.