NCT04588701

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
483

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1996

Longer than P75 for all trials

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 11, 1996

Completed
22.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

22.9 years

First QC Date

October 9, 2020

Last Update Submit

October 14, 2020

Conditions

Fistula in Ano

Keywords

anal fistulafistulotomyano-rectal advancement flapsphincter saving

Outcome Measures

Primary Outcomes (1)

  • Number of patients who heal after simple or staged operations for fistula

    typically 1 year, but up to 4 years

Study Arms (1)

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

Interventions

surgical procedures commonly done for anal fistulaPROCEDURE

Surgical procedures performed, including fistulotomy; fistulotomy with sphincter repair; seton; advancement flap; fistula plug;

persons with anal fistulas

Eligibility Criteria

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

You may qualify if:

  • anal fistulas

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Richard E Burney, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Emeritus of Surgery

Study Record Dates

First Submitted

October 9, 2020

First Posted

October 19, 2020

Study Start

January 11, 1996

Primary Completion

December 17, 2018

Study Completion

December 17, 2018

Last Updated

October 19, 2020

Record last verified: 2020-10