CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 160 enrolled
Drug / intervention
End-to-end repair of the external anal sphincter muscle +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00439907
NCT00439907N/ACompleted
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A Prospective, Randomized Study Comparing the Outcome of Overlap and End-to-end Repair in Anal Sphincter Rupture During Delivery

Helse Stavanger HF·interventional·Posted Feb 26, 2007·Updated Jul 28, 2015

In Brief

A clinical study evaluating End-to-end repair of the external anal sphincter muscle and Overlap repair of the external anal sphincter muscle for Rupture and Childbirth. Completed, enrolled 160 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRupture, Childbirth
CountriesNorway
Collaborators--

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 26, 2007
Enrollment StartFeb 1, 2005
Primary CompletionFeb 1, 2008
Study CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 19.3 years ago

Interventions

End-to-end repair of the external anal sphincter muscleprocedure

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

Overlap repair of the external anal sphincter muscleprocedure

Surgical procedure: Overlap repair of the external anal sphincter muscle