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

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

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.

Study Overview

• Status: Completed
• Conditions: Rupture; Childbirth
• Intervention / Treatment: Procedure: End-to-end repair of the external anal sphincter muscle; 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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Stavanger, Norway, NO-4011
    • Stavanger University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Delivery
• Anal sphincter rupture

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Anal Sonography	pre-partum
Endoanal manometry	pre-partum

Collaborators and Investigators

• Sponsor: Helse Stavanger HF
• Investigators: Principal Investigator: Astrid Rygh, MD, Helse Stavanger HF

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2005
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: February 23, 2007
• First Submitted That Met QC Criteria: February 23, 2007
• First Posted (Estimate): February 26, 2007

Study Record Updates

• Last Update Posted (Estimate): July 28, 2015
• Last Update Submitted That Met QC Criteria: July 27, 2015
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Primary repair; Anal manometry; Anal sphincter; Anal sphincter rupture; Anal sphincter Delivery; End-to-end repair; Over-lap repair; Anal sonography; Weksner Score; Rupture of the external anal sphincter during delivery
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: SF2005-07