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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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