Primary Repair of Obstetric Anal Sphincter Injuries (OASIS) by Surgeons (PROS Study) (PROS)

April 3, 2024 updated by: London North West Healthcare NHS Trust

Primary Repair of Obstetric Anal Sphincter Injuries (OASIS): a Survey of Emergency Surgeons' Experience

Third- or fourth-degree perineal tears, collectively known as Obstetric Anal Sphincter Injuries or OASIS, may occur following a vaginal birth. OASIS may have catastrophic consequences, including anal incontinence. Satisfactory primary repair of OASIS is prudent in reducing the risk of maternal morbidity. Although Obstetricians are typically involved in the acute repair of OASIS, General Surgeons may be called to assist in cases of severe anatomical disruption.

The investigators have constructed a survey to explore the experience and current practice of Emergency Surgeons in relation to the repair of OASIS. The investigators will gather information including their level of exposure, understanding of current guidelines and confidence in performing these repairs. This will help the investigators identify if further training is required and will enable them to put forward recommendations for future practice. The findings will be presented at conferences and meetings and published in journals.

Study Overview

Status

Completed

Conditions

Detailed Description

To date, there is little consensus on who should perform the primary repair of obstetric anal sphincter injuries (OASIS), with the Royal College of Obstetricians and Gynaecologists (RCOG) stating that the repair should be undertaken by a trained practitioner and that 'involvement of a colorectal surgeon will be dependent on local protocols, expertise and availability'.

In cases of severe anatomical disruption, the on-call general surgeon may be summoned upon to assist with the repair. They may not be a colorectal surgeon, and if they are, they may not specialise in pelvic floor surgery. A previous survey of practice amongst UK obstetricians and coloproctologists identified a wide variation in experience, methods of repair, follow up and recommendations for future delivery.

The aim of this study is to explore emergency surgeons' knowledge in relation to the acute repair of OASIS and to compare this with current recommendations and best practice guidance. This, in turn, will help identify if further training is required.

Satisfactory repair of acute OASIS is necessary for the following reasons:

  • It may reduce the risk of anal incontinence, a stigmatising condition which may have substantial impact on an individual's quality of life and day-to-day living.
  • By reducing the incidence of OASIS-related anal incontinence, the financial burden associated with the management of this condition as well as the risk of litigation will also be reduced

Study Type

Observational

Enrollment (Actual)

310

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • London North West University Hospital NHS Trust

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Emergency general surgeons (registrar or consultant level) are eligible to participate. This includes registrar trainees (StR), staff grades, associate specialists, speciality doctors and consultants who are on the speciality register. They will need to be participating in an emergency on-call rota and working in Great Britain and Ireland.

Description

Inclusion Criteria:

  • Registrar or above
  • Cover an Emergency on-call rota for General Surgery
  • Working in Great Britain and Ireland

Exclusion Criteria:

  • • Senior House Officers or Foundation Doctors

    • Doctors who do not cover an emergency rota
    • Doctors working abroad

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of Knowledge
Time Frame: study to be completed over a 12 month period
Ascertainment of the knowledge of trainee, SAS and consultant (varying in age, sub-speciality and region) knowledge and skills in primary OASI repairs, in guideline and policy-related documents and adherence to management recommendations, using a questionnaire
study to be completed over a 12 month period
Training and confidence
Time Frame: study to be completed over a 12 month period
Effect of the number of OASI repairs performed throughout the career of trainees, SAS and consultants (varying in age, sub-speciality and region) and training received, on confidence in performing OASI repairs, using a questionnaire
study to be completed over a 12 month period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge-related attitudes
Time Frame: study to be completed over a 12 month period
Accurate mapping of the pathway of patient follow-up processes following OASI repairs, using a questionnaire
study to be completed over a 12 month period

Collaborators and Investigators

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

Sponsor

London North West Healthcare NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 30, 2023

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

June 1, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 326703

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Obstetric Anal Sphincter Injury

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe