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

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT03983174

Collaborator

(none)

100

Enrollment

Location

Arms

27.9

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Anal Cancer	Procedure: Drainage seton with flap Procedure: EAS sparing seton	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Apr 30, 2018

Actual Study Completion Date :

Apr 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Drainage seton with flap Drainage seton will be put around the external anal sphincter with mucosal advancement flap	Procedure: Drainage seton with flap Seton is placed around the external sphincter then mucosal advancement flap will be constructed
Experimental: EAS sparing seton Rerouting of the seton around the internal anal sphincter sparing the external sphincter will be done	Procedure: EAS sparing seton Rerouting of the seton around the internal sphincter only sparing the external sphincter

Arm

Intervention/Treatment

Experimental: Drainage seton with flap

Drainage seton will be put around the external anal sphincter with mucosal advancement flap

Procedure: Drainage seton with flap

Seton is placed around the external sphincter then mucosal advancement flap will be constructed

Experimental: EAS sparing seton

Rerouting of the seton around the internal anal sphincter sparing the external sphincter will be done

Procedure: EAS sparing seton

Rerouting of the seton around the internal sphincter only sparing the external sphincter

Outcome Measures

Primary Outcome Measures

fecal incontinence [12 months after surgery]
Number of patients who develop fecal incontinence as assessed by Wexner Incontinence score

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura university hospital	Mansourah	Dakahlia	Egypt	35516

Sponsors and Collaborators

Mansoura University

Investigators

Principal Investigator: Sameh Emile, M.D., Mansoura University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sameh Emile, Principal investigator, Mansoura University

ClinicalTrials.gov Identifier:

NCT03983174

Other Study ID Numbers:

Mansoura102

First Posted:

Jun 12, 2019

Last Update Posted:

Jun 18, 2019

Last Verified:

Jun 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anus Neoplasms

Rectal Fistula

Fistula

Study Results

No Results Posted as of Jun 18, 2019