A Modified Surgical Approach to Women With Obstetric Anal Sphincter Tears

This study has been completed.
Sponsor:
Collaborators:
Lund University
Region Skane
Information provided by:
Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01021722
First received: November 27, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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]).


Condition Intervention Phase
Obstetric Surgical Procedures
Procedure: modified suture technique
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Modified Surgical Approach to Women With Obstetric Anal Sphincter Tears

Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Differences in anal incontinence score between a study group and two control groups [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 239
Study Start Date: November 2002
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sphincter tear > grad 3B

Exclusion Criteria:

  • No
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01021722

Locations
Sweden
UMAS
Malmö, Sweden, 20502
Sponsors and Collaborators
Karolinska University Hospital
Lund University
Region Skane
Investigators
Principal Investigator: Pelle G Lindqvist KarolinskaUniversity Hospital
  More Information

No publications provided

Responsible Party: Pelle Lindqvist, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01021722     History of Changes
Other Study ID Numbers: sphincter2009
Study First Received: November 27, 2009
Last Updated: November 27, 2009
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Karolinska University Hospital:
sphincter
obstetric tears
long-term follow-up

ClinicalTrials.gov processed this record on October 01, 2014