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Clinical Trials/NCT04796376
NCT04796376UnknownNot Applicable

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

Assiut University1 site in 1 country25 target enrollmentStarted: October 10, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
25
Locations
1
Primary Endpoint
- Cure of high perianal fistulas -Reduce incontinence rate

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Cutting seton

Other

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.

Intervention: combined partial fistulectomy or fistulotomy and cutting seton procedure (Procedure)

Outcomes

Primary Outcomes

- Cure of high perianal fistulas -Reduce incontinence rate

Time Frame: 1 year

Cure from the main problem of the patient and prevent its recurrence

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mina Nabil Zaher

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

Assiut University

Study Sites (1)

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