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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Randomized Study Comparing the Outcome of Overlap and End-to-end Repair in Anal Sphincter Rupture During Delivery

Conditions
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Rupture, Childbirth

Intervention / Treatment
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* Procedure: End-to-end repair of the external anal sphincter muscle
* Procedure: Overlap repair of the external anal sphincter muscle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Delivery Anal sphincter rupture Exclusion Criteria: Lack of ability to understand the informed consent form Lack of ability to cooperate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: End-to-end<br>End-to-end repair | Procedure: End-to-end repair of the external anal sphincter muscle<br>* Surgical procedure: End-to-end repair of the external anal sphincter muscle<br>|
| Active Comparator: Overlap<br>Overlap repair | Procedure: Overlap repair of the external anal sphincter muscle<br>* Surgical procedure: Overlap repair of the external anal sphincter muscle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anal Sonography |  | pre-partum | 
| Endoanal manometry |  | pre-partum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anal sphincter Delivery, Primary repair, End-to-end repair, Over-lap repair, Anal manometry, Anal sonography, Weksner Score, Rupture of the external anal sphincter during delivery, Anal sphincter, Anal sphincter rupture