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

Overview

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

Full Title of Study: “Drainage Seton Around the External Anal Sphincter With Mucosal Advancement Flap Versus External Anal Sphincter Preserving Seton in Treatment of Trans-sphincteric Anal Fistula”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: April 30, 2018

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Drainage seton with flap
    • Drainage seton will be put around the external anal sphincter with mucosal advancement flap
  • Experimental: EAS sparing seton
    • Rerouting of the seton around the internal anal sphincter sparing the external sphincter will be done

Clinical Trial Outcome Measures

Primary Measures

  • fecal incontinence
    • Time Frame: 12 months after surgery
    • Number of patients who develop fecal incontinence as assessed by Wexner Incontinence score

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mansoura University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sameh Emile, Principal investigator – Mansoura University
  • Overall Official(s)
    • Sameh Emile, M.D., Principal Investigator, Mansoura University

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