Randomised Controlled Trial (RCT) comparing two methods of repairing external anal sphincter lacerations

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN04149919

Enrollment

150

Registered

2005-09-01

Start date

2000-10-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Third or Fourth degree tear of the External Anal Sphincter (EAS) at childbirth. Pregnancy and Childbirth External Anal Sphincter repair

Interventions

Two arms: 1. Traditional end-to-end repair of the EAS 2. Overlapping repair of the EAS

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Complete third or fourth degree tear of the External Anal Sphincter 2. Aged 18 - 49 years old, female

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Rate of flatal incontinence at 6 months post repair.	—

Secondary

Measure	Time frame
1. Rate of fecal incontinence at 6 months post repair 2. Integrity of EAS by endoanal ultrasound 3. Function of EAS by anal manometry 4. Quality of life by validated QOL measure 5. Post-operative complications	—

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 31, 2026