A Modified Surgical Approach to Women With Obstetric Anal Sphincter Tears
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|ClinicalTrials.gov Identifier: NCT01021722|
Recruitment Status : Completed
First Posted : November 30, 2009
Last Update Posted : November 30, 2009
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 or disease||Intervention/treatment||Phase|
|Obstetric Surgical Procedures||Procedure: modified suture technique||Phase 4|
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:
- Adoption of a structured way of describing the damage according to Fornell an co-workers and recommended by RCOG. 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
- 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).
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||239 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Modified Surgical Approach to Women With Obstetric Anal Sphincter Tears|
|Study Start Date :||November 2002|
|Primary Completion Date :||August 2005|
|Study Completion Date :||August 2005|
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
No Intervention: Historical sphincter group
The outcome of historical sphincter tears
No Intervention: Normal primaparous deliveries
- Differences in anal incontinence score between a study group and two control groups [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021722
|Malmö, Sweden, 20502|
|Principal Investigator:||Pelle G Lindqvist||KarolinskaUniversity Hospital|