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A Modified Surgical Approach to Women With Obstetric Anal Sphincter Tears

NCT01021722 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 239

Last updated 2009-11-30

No results posted yet for this study

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 \[n = 100\]).

Conditions

  • Obstetric Surgical Procedures

Interventions

PROCEDURE

modified suture technique

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

Sponsors & Collaborators

  • Lund University

    collaborator OTHER

  • Region Skane

    collaborator OTHER

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • Pelle G Lindqvist · KarolinskaUniversity Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-30
Primary Completion
2005-08-31
Completion
2005-08-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01021722 on ClinicalTrials.gov