Long Term Outcomes After Surgery for Anal Fistula | NCT04588701

Studies
Long Term Outcomes After Surgery for Anal Fistula

NCT04588701

Sponsor

University of Michigan

Status

Completed

Last Update Posted

Oct 19, 2020Actual

Enrollment

483Actual

Phase

Not provided

Conditions

Fistula in Ano

Interventions

surgical procedures commonly done for anal fistula

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 11, 1996Actual

Primary Completion Date

Dec 17, 2018Actual

Completion Date

Dec 17, 2018Actual

First Submitted Date

Oct 9, 2020

First Submission Date that Met QC Criteria

Oct 14, 2020

First Posted Date

Oct 19, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2020

Last Update Posted Date

Oct 19, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

483Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
surgical procedures commonly done for anal fistula	Procedure	Surgical procedures performed, including fistulotomy; fistulotomy with sphincter repair; seton; advancement flap; fistula plug;

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

anal fistulas

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard E Burney, MD	University of Michigan	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012003	Rectal Fistula

Ancestor Terms

ID	Term
D007412	Intestinal Fistula
D016154	Digestive System Fistula
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided