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

NCT ID: NCT04796376

Last Updated: 2021-03-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-10
• Study Completion Date: 2023-03-31

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.

Conditions

High Anal Fistula

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cutting seton

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.

Group Type: OTHER

combined partial fistulectomy or fistulotomy and cutting seton procedure

Intervention Type: PROCEDURE

Partial excision of fistulous tract or just fistulotomy plus cutting seton procedure which is a rubber band or threads put through fistulous tract

Interventions

combined partial fistulectomy or fistulotomy and cutting seton procedure

Partial excision of fistulous tract or just fistulotomy plus cutting seton procedure which is a rubber band or threads put through fistulous tract

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mina Nabil Zaher

Resident at General surgery department, faculty of medicine, Assiut University, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mina Nb Zaher, Resident doc

Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut University

Asyut, , Egypt

Countries

Egypt

Other Identifiers

AssiutU MNZaher

Identifier Type: -

Identifier Source: org_study_id