NCT03983174

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2019

Completed
Last Updated

June 18, 2019

Status Verified

June 1, 2019

Enrollment Period

1.3 years

First QC Date

June 10, 2019

Last Update Submit

June 15, 2019

Conditions

Anal Cancer

Outcome Measures

Primary Outcomes (1)

  • fecal incontinence

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

    12 months after surgery

Study Arms (2)

Drainage seton with flap

EXPERIMENTAL

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

Procedure: Drainage seton with flap

EAS sparing seton

EXPERIMENTAL

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

Procedure: EAS sparing seton

Interventions

Drainage seton with flapPROCEDURE

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

Drainage seton with flap
EAS sparing setonPROCEDURE

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

EAS sparing seton

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suffering from high trans-sphincteric anal fistula

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Anus Neoplasms

Interventions

Surgical Flaps

Condition Hierarchy (Ancestors)

Rectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Surgically-Created StructuresEquipment and Supplies

Study Officials

  • Sameh Emile, M.D.

    Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 10, 2019

First Posted

June 12, 2019

Study Start

January 1, 2017

Primary Completion

April 30, 2018

Study Completion

April 30, 2019

Last Updated

June 18, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)