A Modified Surgical Approach to Women With Obstetric Anal Sphincter Tears
NCT ID: NCT01021722
Last Updated: 2009-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
239 participants
INTERVENTIONAL
2002-11-30
2005-08-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Modified suture technique
Sutured in a modified manner
modified suture technique
Both internal and external anal sphincter was sutured separately end to end
Historical sphincter group
The outcome of historical sphincter tears
No interventions assigned to this group
Normal primaparous deliveries
Normal deliveries
No interventions assigned to this group
Interventions
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modified suture technique
Both internal and external anal sphincter was sutured separately end to end
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Lund University
OTHER
Region Skane
OTHER
Karolinska University Hospital
OTHER
Responsible Party
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Karolinska University Hospital
Principal Investigators
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Pelle G Lindqvist
Role: PRINCIPAL_INVESTIGATOR
KarolinskaUniversity Hospital
Locations
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UMAS
Malmo, , Sweden
Countries
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Other Identifiers
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sphincter2009
Identifier Type: -
Identifier Source: org_study_id