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

Helse Stavanger HF

Status: Completed

Conditions: Rupture; Childbirth

Treatments: Procedure: Overlap repair of the external anal sphincter muscle; Procedure: End-to-end repair of the external anal sphincter muscle

Study type: Interventional

Funder types: Other

Identifiers

NCT00439907

SF2005-07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Delivery
• Anal sphincter rupture

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

End-to-end

Active Comparator group

Description:

End-to-end repair

Treatment:

Procedure: End-to-end repair of the external anal sphincter muscle

Overlap

Active Comparator group

Description:

Overlap repair

Treatment:

Procedure: Overlap repair of the external anal sphincter muscle