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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| End-to-end | Active Comparator | End-to-end repair |
|
| Overlap | Active Comparator | Overlap repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| End-to-end repair of the external anal sphincter muscle | Procedure | Surgical procedure: End-to-end repair of the external anal sphincter muscle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anal Sonography | pre-partum | |
| Endoanal manometry | pre-partum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Astrid Rygh, MD | Helse Stavanger HF | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stavanger University Hospital | Stavanger | NO-4011 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10426237 | Background | Sultan AH, Monga AK, Kumar D, Stanton SL. Primary repair of obstetric anal sphincter rupture using the overlap technique. Br J Obstet Gynaecol. 1999 Apr;106(4):318-23. doi: 10.1111/j.1471-0528.1999.tb08268.x. | |
| 11084569 | Background | Fitzpatrick M, Behan M, O'Connell PR, O'Herlihy C. A randomized clinical trial comparing primary overlap with approximation repair of third-degree obstetric tears. Am J Obstet Gynecol. 2000 Nov;183(5):1220-4. doi: 10.1067/mob.2000.108880. |
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| ID | Term |
|---|---|
| D012421 | Rupture |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Overlap repair of the external anal sphincter muscle | Procedure | Surgical procedure: Overlap repair of the external anal sphincter muscle |
|
| 20846058 | Derived | Rygh AB, Korner H. The overlap technique versus end-to-end approximation technique for primary repair of obstetric anal sphincter rupture: a randomized controlled study. Acta Obstet Gynecol Scand. 2010 Oct;89(10):1256-62. doi: 10.3109/00016349.2010.512073. |