NCT01021722

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 \[n = 100\]).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2002

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 30, 2009

Completed
Last Updated

November 30, 2009

Status Verified

November 1, 2009

Enrollment Period

2.8 years

First QC Date

November 27, 2009

Last Update Submit

November 27, 2009

Conditions

Obstetric Surgical Procedures

Keywords

sphincterobstetric tearslong-term follow-up

Outcome Measures

Primary Outcomes (1)

  • Differences in anal incontinence score between a study group and two control groups

    1 year

Study Arms (3)

Modified suture technique

EXPERIMENTAL

Sutured in a modified manner

Procedure: modified suture technique

Historical sphincter group

NO INTERVENTION

The outcome of historical sphincter tears

Normal primaparous deliveries

NO INTERVENTION

Normal deliveries

Interventions

modified suture techniquePROCEDURE

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

Also known as: Historical sphincter tears, Historical normal deliveries
Modified suture technique

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sphincter tear \> grad 3B

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMAS

Malmo, 20502, Sweden

Location

Study Officials

  • Pelle G Lindqvist

    KarolinskaUniversity Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 27, 2009

First Posted

November 30, 2009

Study Start

November 1, 2002

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

November 30, 2009

Record last verified: 2009-11

Locations

SE(1)