Randomised Controlled Trial (RCT) comparing two methods of repairing external anal sphincter lacerations
Completed
- Conditions
- Third or Fourth degree tear of the External Anal Sphincter (EAS) at childbirth.Pregnancy and ChildbirthExternal Anal Sphincter repair
- Registration Number
- ISRCTN04149919
- Lead Sponsor
- Dalhousie University (Nova Scotia) (Canada)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 150
Inclusion Criteria
1. Complete third or fourth degree tear of the External Anal Sphincter
2. Aged 18 - 49 years old, female
Exclusion Criteria
1. Previous 3rd or 4th degree tear
2. Significant history of anal incontinence
3. Inflammatory bowel disease or other gastrointestinal condition which might affect functional outcome
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of flatal incontinence at 6 months post repair.
- Secondary Outcome Measures
Name Time Method 1. Rate of fecal incontinence at 6 months post repair<br>2. Integrity of EAS by endoanal ultrasound<br>3. Function of EAS by anal manometry<br>4. Quality of life by validated QOL measure<br>5. Post-operative complications