Video-assisted Anal Fistula Treatment (VAAFT) Versus Fistula-tract Laser Closure (Filac) Versus Conventional Seton in the Management of Anal Fistula

June 17, 2020 updated by: Mansoura University
Anal fistula is a chronic inflammatory tract connecting an internal opening in the anal canal with one or more than one external openings in the perianal skin Aim of the work This prospective randomized control trial, we will compare video-assisted anal fistula treatment (Vaaft) and Fistula Laser closure (Filac) and conventional Seton as regards, recurrence rate as a primary outcome. Secondary outcome includes; operative and post-operative data, hospital stay, pain score, healing time, return to work and continence

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt
        • Recruiting
        • Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of both genders aging between 18-65 years with cryptoglandular anal fistula will be included.

Exclusion Criteria:

  • We will exclude patients with associated anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases, and patients on long acting corticosteroids or immunosuppressive drugs will be also excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Video-assisted anal fistula treatment (VAAFT
Video-assisted anal fistula treatment (VAAFT) in the Management of anal fistula
Procedure: Video-assisted anal fistula treatment (VAAFT) versus Fistula-tract Laser Closure (filac) versus Conventional seton in the Management of anal fistula
Video-assisted anal fistula treatment (VAAFT) versus Fistula-tract Laser Closure (filac) versus Conventional seton in the Management of anal fistula
Active Comparator: Fistula-tract Laser Closure (filac)
Fistula-tract Laser Closure (filac)in the Management of anal fistula
Procedure: Video-assisted anal fistula treatment (VAAFT) versus Fistula-tract Laser Closure (filac) versus Conventional seton in the Management of anal fistula
Video-assisted anal fistula treatment (VAAFT) versus Fistula-tract Laser Closure (filac) versus Conventional seton in the Management of anal fistula
Active Comparator: Conventional seton
Conventional seton in the Management of anal fistula
Procedure: Video-assisted anal fistula treatment (VAAFT) versus Fistula-tract Laser Closure (filac) versus Conventional seton in the Management of anal fistula
Video-assisted anal fistula treatment (VAAFT) versus Fistula-tract Laser Closure (filac) versus Conventional seton in the Management of anal fistula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence of anal fistula
Time Frame: one year
recurrence of anal fistula symptoms
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2020

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 2, 2021

Study Registration Dates

First Submitted

June 3, 2020

First Submitted That Met QC Criteria

June 3, 2020

First Posted (Actual)

June 5, 2020

Study Record Updates

Last Update Posted (Actual)

June 18, 2020

Last Update Submitted That Met QC Criteria

June 17, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R.19.03.453 - 2019/03/11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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