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

This study has been completed.
Sponsor:
Information provided by:
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT00439907
First received: February 23, 2007
Last updated: August 2, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention
Rupture
Childbirth
Procedure: End-to-end repair of the external anal sphincter muscle
Procedure: Overlap repair of the external anal sphincter muscle

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Study Comparing the Outcome of Overlap and End-to-end Repair in Anal Sphincter Rupture During Delivery

Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • Anal Sonography [ Time Frame: pre-partum ] [ Designated as safety issue: Yes ]
  • Endoanal manometry [ Time Frame: pre-partum ] [ Designated as safety issue: Yes ]

Enrollment: 160
Study Start Date: February 2005
Study Completion Date: April 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: End-to-end
End-to-end repair
Procedure: End-to-end repair of the external anal sphincter muscle
Surgical procedure: End-to-end repair of the external anal sphincter muscle
Active Comparator: Overlap
Overlap repair
Procedure: Overlap repair of the external anal sphincter muscle
Surgical procedure: Overlap repair of the external anal sphincter muscle

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Delivery
  • Anal sphincter rupture

Exclusion Criteria:

  • Lack of ability to understand the informed consent form
  • Lack of ability to cooperate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00439907

Locations
Norway
Stavanger University Hospital
Stavanger, Norway, NO-4011
Sponsors and Collaborators
Helse Stavanger HF
Investigators
Principal Investigator: Astrid Rygh, MD Helse Stavanger HF
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Torbjørn Moe Eggebø, Stavanger University Hospital
ClinicalTrials.gov Identifier: NCT00439907     History of Changes
Other Study ID Numbers: SF2005-07
Study First Received: February 23, 2007
Last Updated: August 2, 2010
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Helse Stavanger HF:
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

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014