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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04588701
Other study ID # HUM00168195
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 11, 1996
Est. completion date December 17, 2018

Study information

Verified date October 2020
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 483
Est. completion date December 17, 2018
Est. primary completion date December 17, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - anal fistulas Exclusion Criteria: - none

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
surgical procedures commonly done for anal fistula
Surgical procedures performed, including fistulotomy; fistulotomy with sphincter repair; seton; advancement flap; fistula plug;

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients who heal after simple or staged operations for fistula typically 1 year, but up to 4 years
See also
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Recruiting NCT04187651 - PRP Use in Treatment of Fistula Ano N/A
Completed NCT04069728 - The Impact of 3D Anal Fistula Models on Patient Understanding and Decision Making N/A
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Recruiting NCT05039411 - Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas Patients With Crohn's Disease Phase 1
Completed NCT01880398 - Management of Fistula in Ano by Kshar Sutra, Para Surgical Procedure. N/A
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Completed NCT06212739 - Post-op Pain After Fistula Laser Closure or Ligation of the Intersphincteric Tract for Anal Fistula N/A
Completed NCT01954225 - Role of Udumbara Sutra in the Management of Fistula in Ano a Rare Case Study N/A
Completed NCT05223309 - High Type Fistula in Ano, Use Staged Seton, Loose Thick Sutures
Terminated NCT02686580 - Feasibility Study to Assess the Early Use of Porcine Cross-linked Collagen Paste in Cryptoglandular Anorectal Fistulas Phase 3
Completed NCT05660876 - Fistulotomy Versus Fistulotomy With Marsupialization N/A
Recruiting NCT04161469 - Laser Closure of Anal Fistula (FiLaC) N/A
Completed NCT04215718 - Fistulotomy With Marsupialization Versus Fistulectomy With Wound Sutures in Simple Anal Fistula N/A