Skip to content

A Modified Surgical Approach to Women With Obstetric Anal Sphincter Tears

A Modified Surgical Approach to Women With Obstetric Anal Sphincter Tears

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01021722
Enrollment
239
Registered
2009-11-30
Start date
2002-11-30
Completion date
2005-08-31
Last updated
2009-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstetric Surgical Procedures

Keywords

sphincter, obstetric tears, long-term follow-up

Brief 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 \[n = 100\]).

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.

Interventions

PROCEDUREmodified suture technique

Both internal and external anal sphincter was sutured separately end to end

Sponsors

Lund University
CollaboratorOTHER
Region Skane
CollaboratorOTHER
Karolinska University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Sphincter tear \> grad 3B

Exclusion criteria

* No

Design outcomes

Primary

MeasureTime frame
Differences in anal incontinence score between a study group and two control groups1 year

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026