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

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Brief Title

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

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

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
    



Study Type

Interventional


Primary Outcome

fecal incontinence


Condition

Anal Cancer

Intervention

Drainage seton with flap

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

100

Start Date

January 1, 2017

Completion Date

April 30, 2019

Primary Completion Date

April 30, 2018

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Sameh Emile, M.D., , 

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations


NCT ID

NCT03983174

Organization ID

Mansoura102


Responsible Party

Principal Investigator

Study Sponsor

Mansoura University


Study Sponsor

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


Verification Date

June 2019