Comparison of Overlap and End-to-end Repair in Anal Sphincter Rupture During Delivery
Primary Purpose
Rupture, Childbirth
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
End-to-end repair of the external anal sphincter muscle
Overlap repair of the external anal sphincter muscle
Sponsored by
About this trial
This is an interventional treatment trial for Rupture focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
- Delivery
- Anal sphincter rupture
Exclusion Criteria:
- Lack of ability to understand the informed consent form
- Lack of ability to cooperate
Sites / Locations
- Stavanger University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
End-to-end
Overlap
Arm Description
End-to-end repair
Overlap repair
Outcomes
Primary Outcome Measures
Anal Sonography
Endoanal manometry
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00439907
Brief Title
Comparison of Overlap and End-to-end Repair in Anal Sphincter Rupture During Delivery
Official Title
A Prospective, Randomized Study Comparing the Outcome of Overlap and End-to-end Repair in Anal Sphincter Rupture During Delivery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Stavanger HF
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rupture, Childbirth
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
End-to-end
Arm Type
Active Comparator
Arm Description
End-to-end repair
Arm Title
Overlap
Arm Type
Active Comparator
Arm Description
Overlap repair
Intervention Type
Procedure
Intervention Name(s)
End-to-end repair of the external anal sphincter muscle
Intervention Description
Surgical procedure: End-to-end repair of the external anal sphincter muscle
Intervention Type
Procedure
Intervention Name(s)
Overlap repair of the external anal sphincter muscle
Intervention Description
Surgical procedure: Overlap repair of the external anal sphincter muscle
Primary Outcome Measure Information:
Title
Anal Sonography
Time Frame
pre-partum
Title
Endoanal manometry
Time Frame
pre-partum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Delivery
Anal sphincter rupture
Exclusion Criteria:
Lack of ability to understand the informed consent form
Lack of ability to cooperate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Astrid Rygh, MD
Organizational Affiliation
Helse Stavanger HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stavanger University Hospital
City
Stavanger
ZIP/Postal Code
NO-4011
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
10426237
Citation
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.
Results Reference
background
PubMed Identifier
11084569
Citation
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.
Results Reference
background
PubMed Identifier
20846058
Citation
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.
Results Reference
derived
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Comparison of Overlap and End-to-end Repair in Anal Sphincter Rupture During Delivery
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