Transsphincteric Fistula Management Using LIFT and MAF

September 25, 2024 updated by: Tamer.A.A.M.Habeeb, Zagazig University

Comparative Outcomes of Ligation of the Intersphincteric Fistula Tract and Mucosal Advancement Flap Techniques in Elderly Patients with Transsphincteric Perianal Fistulas: Recurrence, Incontinence and Risk Factors

a study that detect the most suitable surgical techniques for treating transsphincteric fistula

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

we compared between LIFT and MAF in elderly with PAF

Study Type

Observational

Enrollment (Actual)

257

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
    • Sharkia
      • Zagazig, Sharkia, Egypt, 44511
        • Faculty of Medicine Zagazig 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

two hundred and fifty seven elderly patient with PAF

Description

Inclusion Criteria:

  • elderly persons with PAF

Exclusion Criteria:

  • recurrent fistula
  • associated autoimmune diseases

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LIFT
Procedure: LIFT
use LIFT surgery for treating PAF
MAF
Procedure: MAF
use mucosal advancement flap to treat PAF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
healing rate
Time Frame: three years
incidence of healing in both approaches
three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incontinence
Time Frame: three years
incidence of incontinence after both approaches
three years

Collaborators and Investigators

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

Sponsor

Zagazig University

Investigators

  • Principal Investigator: Tamer. A.A.M. Habeeb, zagazig 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)

July 1, 2018

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

July 1, 2024

Study Registration Dates

First Submitted

September 23, 2024

First Submitted That Met QC Criteria

September 25, 2024

First Posted (Actual)

September 27, 2024

Study Record Updates

Last Update Posted (Actual)

September 27, 2024

Last Update Submitted That Met QC Criteria

September 25, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • perianal fistula

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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