A Modified Surgical Approach to Women With Obstetric Anal Sphincter Tears

Obstetric Surgical Procedures Clinical Trial

Official title:

A Modified Surgical Approach to Women With Obstetric Anal Sphincter Tears

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01021722
• Other study ID #: sphincter2009
• Status: Completed
• Phase: Phase 4
• First received: November 27, 2009
• Last updated: November 27, 2009
• Start date: November 2002
• Est. completion date: August 2005

Study information

• Verified date: November 2009
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

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]).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Sphincter tear > grad 3B

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstetric Surgical Procedures

Intervention

Procedure:
• modified suture technique
Both internal and external anal sphincter was sutured separately end to end

Locations

Country	Name	City	State
Sweden	UMAS	Malmö

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska University Hospital	Lund University, Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in anal incontinence score between a study group and two control groups		1 year	No