The Outcome of Combined Partial Fistulectomy or Fistulotomy and Cutting Seton Procedure in High Perianal Fistula

Not Applicable

• Conditions: High Anal Fistula
• Interventions: Procedure: combined partial fistulectomy or fistulotomy and cutting seton procedure

• Registration Number: NCT04796376
• Lead Sponsor: Assiut University

Brief Summary

The aim of this study is to assess the effectiveness and suitability of the tight (cutting) seton as a surgical treatment of high anal fistula combined with partial fistulotomy or fistulectomy in a prospective study.

Detailed Description

Anal fistula is an abnormal tract with two openings: external one opens in perianal skin and the internal one opens in anal canal. And according to relation between fistula and anal sphincters there are intersphincteric, transphincteric, suprasphincteric and extrasphincteric. Varieties of surgical procedures are encountered for management of this disease but complications such as recurrence and incontinence still facing surgeons strongly. In previous study of total 31 patients post-operative complications were; incontinence of gas (16.13%), incontinence of stool (3.23%), recurrence (3.23%) with conclusion of that: outcomes of fistulotomy with cutting seton were satisfactory in most patients (1). In this study and aiming to reduce the complications rate data will be collected about the outcomes of combined partial fistulectomy or fistulotomy and cutting seton procedure in a prospective study. The goals of treatment are draining infection, eradicating the fistulous tract and avoiding persistent or recurrent disease while preserving anal sphincter function.

Study Timeline

• Study Start: 2020-10-10
• Status Verified: 2021-02
• Study First Submitted: 2021-02-19
• Study First Submitted QC: 2021-03-11
• Last Update Submitted: 2021-03-11
• Study First Posted: 2021-03-12
• Last Update Posted: 2021-03-12
• Primary Completion: 2021-10
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Adult with age of or above 18 years.
• Patients with high perianal fistula; trans-sphincteric, intra-sphincteric or supra-sphincteric.
• Patients sable to comply to with the study protocol.

Exclusion Criteria

• Patients with low perianal fistula
• Patients with preoperative incontinence.
• Patients with comorbidities such as TB , malignancy or inflammatory bowel disease.
• Patients diagnosed with acute anal sepsis
• Recurrent cases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cutting seton	combined partial fistulectomy or fistulotomy and cutting seton procedure	A piece of surgical thread that's left in the fistula for several weeks to keep it open. This allow it to drain and help its heal.

Primary Outcome Measures

Name	Time	Method
- Cure of high perianal fistulas -Reduce incontinence rate	1 year	Cure from the main problem of the patient and prevent its recurrence

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt