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

NCT00439907 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2015-07-28

No results posted yet for this study

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.

Conditions

  • Rupture
  • Childbirth

Interventions

PROCEDURE

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

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

PROCEDURE

Overlap repair of the external anal sphincter muscle

Surgical procedure: Overlap repair of the external anal sphincter muscle

Sponsors & Collaborators

  • Helse Stavanger HF

    lead OTHER_GOV

Principal Investigators

  • Astrid Rygh, MD · Helse Stavanger HF

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2008-02-29
Completion
2008-04-30

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00439907 on ClinicalTrials.gov