Anal Incontinence After Obstetrical Anal Sphincter Injury

NCT ID: NCT04940494

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

227 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-07-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Obstetrical Anal Sphincter Injury is an identified risk factor for anal incontinence. The mechanisms and the risk factors for anal incontinence in Obstetrical Anal Sphincter Injury women are not well known.

Anal incontinence in such women is not well documented and probably underestimated. Cohort studies estimated that up to 53% of Obstetrical Anal Sphincter Injury women are incontinent but that most of them does not complain their doctor.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obstetric Trauma Anal Sphincter Injury Anal Incontinence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

collection of data

collection of data for all Obstetrical Anal Sphincter Injury women (score of quality of life, experimenting anal incontinence...)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Childbirth between 2005 January 1st and 2019 December 31th
* Obstetrical Anal Sphincter Injury -≥ 18 y

Exclusion Criteria

* Patients' refusal
* lost of view or deceased
* anal incontinence before the Obstetrical Anal Sphincter Injury
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Aurélien VENARA, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Angers

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Angers

Angers, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Rebmann E, Hamel JF, Helbert C, Lemasson F, Legendre G, Venara A. Anal incontinence after obstetrical anal sphincter injury significantly impacts quality of life for women: a cohort study. Langenbecks Arch Surg. 2024 Feb 17;409(1):67. doi: 10.1007/s00423-024-03257-4.

Reference Type DERIVED
PMID: 38368278 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-A01128-33

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.