Childbirth, Rupture
Conditions
Keywords
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
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.
Interventions
Surgical procedure: End-to-end repair of the external anal sphincter muscle
Surgical procedure: Overlap repair of the external anal sphincter muscle
Sponsors
Study design
Eligibility
Inclusion criteria
* Delivery * Anal sphincter rupture
Exclusion criteria
* Lack of ability to understand the informed consent form * Lack of ability to cooperate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anal Sonography | pre-partum |
| Endoanal manometry | pre-partum |
Countries
Norway