Clinical trial NCT01021722: A Modified Surgical Approach to Women With Obstetric Anal Sphincter Tears
Official title: A Modified Surgical Approach to Women With Obstetric Anal Sphincter Tears
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obstetric Surgical Procedures
Keywords: sphincter
obstetric tears
long-term follow-up
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Lund University
name: Region Skane
First posted: 2009-11-30
Enrollment: 239
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Sphincter tear \> grad 3B

Exclusion Criteria:

* No

Primary outcomes:
measure: Differences in anal incontinence score between a study group and two control groups
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: UMAS
Study officials:
affiliation: KarolinskaUniversity Hospital
name: Pelle G Lindqvist
role: PRINCIPAL_INVESTIGATOR
References: