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| Sponsors and Collaborators: |
Stavanger Health Research Stavanger University Hospital |
|---|---|
| Information provided by: | Stavanger Health Research |
| ClinicalTrials.gov Identifier: | NCT00439907 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Rupture Childbirth |
Procedure: End-to-end repair of the external anal sphincter muscle Procedure: Overlap repair of the external anal sphincter muscle |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Prospective, Randomized Study Comparing the Outcome of Overlap and End-to-End Repair in Anal Sphincter Rupture During Delivery |
| Estimated Enrollment: | 160 |
| Study Start Date: | February 2005 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
End-to-end repair
|
Procedure: End-to-end repair of the external anal sphincter muscle
Surgical procedure: End-to-end repair of the external anal sphincter muscle
|
|
2: Active Comparator
Overlap repair
|
Procedure: Overlap repair of the external anal sphincter muscle
Surgical procedure: Overlap repair of the external anal sphincter muscle
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Norway | |
| Stavanger University Hospital | |
| Stavanger, Norway, NO-4011 | |
| Principal Investigator: | Astrid Rygh, MD | Stavanger University Hospital |
More Information
| Responsible Party: | Stavanger University Hospital ( Torbjørn Moe Eggebø ) |
| Study ID Numbers: | SF2005-07 |
| Study First Received: | February 23, 2007 |
| Last Updated: | June 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00439907 |
| Health Authority: | Norway: The National Committees for Research Ethics in Norway |
|
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 |
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Wounds and Injuries Disorders of Environmental Origin Rupture |
