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NCT03983174 Clinical Trial

Drainage Seton With Flap Versus EAS Preserving Seton in Treatment of Transsphincteric Anal Fistula

Anal Cancer Clinical Trial

Official title:
Drainage Seton Around the External Anal Sphincter With Mucosal Advancement Flap Versus External Anal Sphincter Preserving Seton in Treatment of Trans-sphincteric Anal Fistula

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03983174
Other study ID # Mansoura102
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2017
Est. completion date April 30, 2019

Study information
Verified date June 2019
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date April 30, 2019
Est. primary completion date April 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Drainage seton with flap
Seton is placed around the external sphincter then mucosal advancement flap will be constructed
• EAS sparing seton
Rerouting of the seton around the internal sphincter only sparing the external sphincter

Locations
Country Name City State
Egypt Mansoura university hospital Mansourah Dakahlia

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary fecal incontinence Number of patients who develop fecal incontinence as assessed by Wexner Incontinence score 12 months after surgery
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