NCT00439907

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

July 28, 2015

Status Verified

August 1, 2010

Enrollment Period

3 years

First QC Date

February 23, 2007

Last Update Submit

July 27, 2015

Conditions

RuptureChildbirth

Keywords

Anal sphincter DeliveryPrimary repairEnd-to-end repairOver-lap repairAnal manometryAnal sonographyWeksner ScoreRupture of the external anal sphincter during deliveryAnal sphincterAnal sphincter rupture

Outcome Measures

Primary Outcomes (2)

  • Anal Sonography

    pre-partum

  • Endoanal manometry

    pre-partum

Study Arms (2)

End-to-end

ACTIVE COMPARATOR

End-to-end repair

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

Overlap

ACTIVE COMPARATOR

Overlap repair

Procedure: Overlap repair of the external anal sphincter muscle

Interventions

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

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

End-to-end
Overlap repair of the external anal sphincter musclePROCEDURE

Surgical procedure: Overlap repair of the external anal sphincter muscle

Overlap

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Delivery
  • Anal sphincter rupture

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stavanger University Hospital

Stavanger, NO-4011, Norway

Location

Related Publications (3)

  • 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.

    PMID: 10426237BACKGROUND

  • 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.

    PMID: 11084569BACKGROUND

  • 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.

    PMID: 20846058DERIVED

MeSH Terms

Conditions

Rupture

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Astrid Rygh, MD

    Helse Stavanger HF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2007

First Posted

February 26, 2007

Study Start

February 1, 2005

Primary Completion

February 1, 2008

Study Completion

April 1, 2008

Last Updated

July 28, 2015

Record last verified: 2010-08

Locations

NO(1)