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Comparison of Overlap and End-to-end Repair in Anal Sphincter Rupture During Delivery

A Prospective, Randomized Study Comparing the Outcome of Overlap and End-to-end Repair in Anal Sphincter Rupture During Delivery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00439907
Enrollment
160
Registered
2007-02-26
Start date
2005-02-28
Completion date
2008-04-30
Last updated
2015-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childbirth, Rupture

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

PROCEDUREEnd-to-end repair of the external anal sphincter muscle

Surgical procedure: End-to-end repair of the external anal sphincter muscle

PROCEDUREOverlap repair of the external anal sphincter muscle

Surgical procedure: Overlap repair of the external anal sphincter muscle

Sponsors

Helse Stavanger HF
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frame
Anal Sonographypre-partum
Endoanal manometrypre-partum

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026