A Modified Surgical Approach to Women With Obstetric Anal Sphincter Tears

Long-term results after obstetric anal sphincter tears (AST) is poor. The investigators aim to improve the long-term outcome after AST in terms of symptoms of anal incontinence.

A prospective study at, Malmö University Hospital. Twenty-six women with at least grade 3B AST were classified and sutured in a systematic way, including separate suturing of the internal and external sphincter muscles with monofilament absorbable sutures. The principal outcome was a difference in anal incontinence score, based on six questions, between the study group and two control groups (women with prior AST [n = 180] and primiparous women delivered vaginally without AST [n = 100]).

Study Overview

• Status: Completed
• Conditions: Obstetric Surgical Procedures
• Intervention / Treatment: Procedure: modified suture technique

Detailed Description

The series was undertaken in advance of a planned prospective randomized controlled study. The study was approved by the Research Ethics Committee of Lund University and informed consent was obtained from all the women involved. Twenty-six women presenting with at least a 3B rupture were recruited by one of the two surgeons (MJ, PL). The modified technique included:

1. Adoption of a structured way of describing the damage according to Fornell an co-workers[7] and recommended by RCOG.[8] Grade 3A: any tear of the ESM < 50% Grade 3B: an ESM tear > 50% Grade 3C: related damage to the ISM Grade 4: related rupture of the anal mucosa
2. The use of monofilament resorbable suture material for all sutures in the mucosa or sphincter muscles. The anal mucosa was sutured with a continuous layer of 3.0 glycomer 631 (Biosyn® ,Tyco Healthcare, Mansfield, MA, USA); the ISM with a continuous layer of 3.0 glycomer 631; and the ESM (both superficial and profound portions) with interrupted end-to-end 2.0 glycomer 631 sutures. The perineal body was usually sutured with 2.0 or 3.0 lactomer (Polysorb®, Tyco Healthcare, Mansfield, MA, USA).
3. Metronidazole 1.5g as a single IV injection and/or Cefuroxime 1.5g IV during the procedure and 6 hours post-operative was usually given as prophylaxis.
4. All women were sutured under either regional anaesthesia (spinal, epidural, or pudendal) or general anaesthesia. Thus, the modified procedure included both a new technique of suturing and the operation was performed by one of the two surgeons involved in the study. Apart from this, all women were treated according to routine departmental practice.

• Study Type: Interventional
• Enrollment (Actual): 239
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Malmö, Sweden, 20502
    • UMAS

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:

• Sphincter tear > grad 3B

Exclusion Criteria:

• No

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified suture technique; Sutured in a modified manner	Procedure: modified suture technique; Both internal and external anal sphincter was sutured separately end to end; Other Names: Historical sphincter tears; Historical normal deliveries
No Intervention: Historical sphincter group; The outcome of historical sphincter tears
No Intervention: Normal primaparous deliveries; Normal deliveries

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Differences in anal incontinence score between a study group and two control groups	1 year

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Collaborators: Lund University; Region Skane
• Investigators: Principal Investigator: Pelle G Lindqvist, KarolinskaUniversity Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2002
• Primary Completion (Actual): August 1, 2005
• Study Completion (Actual): August 1, 2005

Study Registration Dates

• First Submitted: November 27, 2009
• First Submitted That Met QC Criteria: November 27, 2009
• First Posted (Estimate): November 30, 2009

Study Record Updates

• Last Update Posted (Estimate): November 30, 2009
• Last Update Submitted That Met QC Criteria: November 27, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: long-term follow-up; sphincter; obstetric tears
• Other Study ID Numbers: sphincter2009