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

High Anal Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04796376
• Other study ID #: AssiutU MNZaher
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 10, 2020
• Est. completion date: March 2023

Study information

• Verified date: February 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: March 2023
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• High Anal Fistula
• Rectal Fistula

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Cure of high perianal fistulas -Reduce incontinence rate	Cure from the main problem of the patient and prevent its recurrence	1 year