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

Childbirth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00439907
• Other study ID #: SF2005-07
• Status: Completed
• Phase: N/A
• First received: February 23, 2007
• Last updated: July 27, 2015
• Start date: February 2005
• Est. completion date: April 2008

Study information

• Verified date: August 2010
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: April 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Delivery

• Anal sphincter rupture

Exclusion Criteria:

• Lack of ability to understand the informed consent form

• Lack of ability to cooperate

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Childbirth
• Rupture

Intervention

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

Locations

Country	Name	City	State
Norway	Stavanger University Hospital	Stavanger

Sponsors (1)

Lead Sponsor	Collaborator
Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anal Sonography		pre-partum	Yes
Primary	Endoanal manometry		pre-partum	Yes