Clinical trial NCT00439907: Comparison of Overlap and End-to-end Repair in Anal Sphincter Rupture During Delivery
Official title: A Prospective, Randomized Study Comparing the Outcome of Overlap and End-to-end Repair in Anal Sphincter Rupture During Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rupture
Childbirth
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
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
First posted: 2007-02-26
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Delivery
* Anal sphincter rupture

Exclusion Criteria:

* Lack of ability to understand the informed consent form
* Lack of ability to cooperate

Primary outcomes:
measure: Anal Sonography
timeFrame: pre-partum
measure: Endoanal manometry
timeFrame: pre-partum
Secondary outcomes:
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital
Study officials:
affiliation: Helse Stavanger HF
name: Astrid Rygh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.