Childbirth Clinical Trial
Official title:
A Prospective, Randomized Study Comparing the Outcome of Overlap and End-to-end Repair in Anal Sphincter Rupture During Delivery
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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