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

Completed

• Conditions: Obstetric Anal Sphincter Injury

• Registration Number: NCT05898945
• Lead Sponsor: London North West Healthcare NHS Trust

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-03-15
• Study Start: 2023-04-30
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-01
• Study First Posted: 2023-06-12
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 310

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Use of Knowledge	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
Training and confidence	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

Secondary Outcome Measures

Name	Time	Method
Knowledge-related attitudes	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

Trial Locations

Locations (1)

London North West University Hospital NHS Trust; 🇬🇧 London, United Kingdom