Comparison of Overlap and End-to-end Repair in Anal Sphincter Rupture During Delivery

Not Applicable

Completed

• Conditions: Childbirth; Rupture
• Interventions: Procedure: Overlap repair of the external anal sphincter muscle; Procedure: End-to-end repair of the external anal sphincter muscle

• Registration Number: NCT00439907
• Lead Sponsor: Helse Stavanger HF

Brief Summary

Rupture of the external anal sphincter occurs in about 4% percent of deliveries. It is not clear from other studies whether the results concerning anal function, e.g. fecal continence, are better with the overlap repair or end-to-end repair of the injured muscle. The researchers randomize women at birth to either overlap or end-to-end when the injury is recognized, and examine them one year later with special anal physiologic examinations and a validated questionnaire. The hypothesis is that the overlap technique is superior.

Detailed Description

Rupture of the external anal sphincter occurs in about 4% percent of deliveries in our department. It is not clear from other studies whether the results concerning anal function are better with the overlap repair or end-to-end repair of the injured muscle. Our routine has been to perform an end-to-end repair, though anal surgeons, in the setting of a secondary repair, prefer the overlap method. Former studies, when the repair was performed by highly skilled operators, have indicated that the overlap method is better.

We wanted to compare the two methods through a RCT with the end-points examination results after one year addressing endoanal sonography findings, anal manometric results and continence score evaluated by a Weksner score questionnaire. Our study is performed in the routine clinical setting. The patients are recruited to the study during delivery when the injury is recognized. When she has given her informed consent she is randomized to one of the two operation methods. The operation is performed by the consultant obstetrician on call or the resident supervised by the consultant. The proctologist who performs the anal manometry and sonography after one year is blinded to the surgical method.

We plan to include approximately 160 patients at one center. In our center we have about 4500 deliveries per year.

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2007-02-23
• Study First Submitted QC: 2007-02-23
• Study First Posted: 2007-02-26
• Primary Completion: 2008-02
• Study Completion: 2008-04
• Status Verified: 2010-08
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

• Delivery
• Anal sphincter rupture

Exclusion Criteria

• Lack of ability to understand the informed consent form
• Lack of ability to cooperate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Overlap	Overlap repair of the external anal sphincter muscle	Overlap repair
End-to-end	End-to-end repair of the external anal sphincter muscle	End-to-end repair

Primary Outcome Measures

Name	Time	Method
Anal Sonography	pre-partum
Endoanal manometry	pre-partum

Trial Locations

Locations (1)

Stavanger University Hospital; 🇳🇴 Stavanger, Norway