Long Term Outcomes After Surgery for Anal Fistula

October 14, 2020 updated by: Richard Burney, University of Michigan
Anal fistula is a common condition with a wide variety of clinical presentations, which can make evaluation and treatment challenging and surgical outcomes uncertain. This study was undertaken to identify lessons learned in the surgical treatment of 483 patients over a 20- year period leading to a pragmatic approach to treatment of this condition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The wide array of variations of anal fistulas makes them challenging both to classify and to treat. The aim of the study is to determine if a systematic approach to their evaluation and surgical treatment, regardless of how one wishes to classify them, can be based on careful assessment of sphincter length and of the anatomical and etiological characteristics of the fistula.

Study Type

Observational

Enrollment (Actual)

483

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all persons with anal fistulas treated by a single surgeon at the University of Michigan Hospital from January 1996 through December 2018

Description

Inclusion Criteria:

  • anal fistulas

Exclusion Criteria:

  • none

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
persons with anal fistulas
all persons with anal fistulas treated by a single surgeon over 22 years
Procedure: surgical procedures commonly done for anal fistula
Surgical procedures performed, including fistulotomy; fistulotomy with sphincter repair; seton; advancement flap; fistula plug;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients who heal after simple or staged operations for fistula
Time Frame: typically 1 year, but up to 4 years
typically 1 year, but up to 4 years

Collaborators and Investigators

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

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Richard E Burney, MD, University of Michigan

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)

January 11, 1996

Primary Completion (Actual)

December 17, 2018

Study Completion (Actual)

December 17, 2018

Study Registration Dates

First Submitted

October 9, 2020

First Submitted That Met QC Criteria

October 14, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 14, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00168195

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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