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CompletedNCT03983174Updated Jun 18, 2019

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

An interventional study of Drainage seton with flap and EAS sparing seton in Anal Cancer, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-06-18.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Jan 2017, registered Jun 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Anal Cancer
03

In context

Anus Neoplasms

266 studies on the registry are indexed under Anus Neoplasms; 71 are open to participants now.

This study's enrollment of 100 is above the median of 70 across 182 interventional studies indexed under Anus Neoplasms.

Browse Anus Neoplasms studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients suffering from high trans-sphincteric anal fistula

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Drainage seton with flap

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

    Procedure: Drainage seton with flap

  • Experimental
    EAS sparing seton

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

    Procedure: EAS sparing seton

Interventions

  • ProcedureDrainage seton with flap

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

  • ProcedureEAS sparing seton

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

06

What researchers measure

Primary outcomes

  1. fecal incontinence

    Number of patients who develop fecal incontinence as assessed by Wexner Incontinence score

    Time frame: 12 months after surgery

07

Study locations

1 site
  • Mansoura university hospital
    Mansourah, Dakahlia 35516, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03983174
Lead sponsor
Mansoura University
Responsible party
Sameh Emile (Principal investigator, Mansoura University) — Principal investigator
First posted
Jun 12, 2019
Start date
Jan 1, 2017
Primary completion
Apr 30, 2018
Completion
Apr 30, 2019
Last update
Jun 18, 2019

Study contacts

Sameh Emile, M.D.
principal investigator · Mansoura University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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