Condition category
Urological and Genital Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
06/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Khaled M K Ismail

ORCID ID

Contact details

Professor of Obstetrics and Gynaecology
School of Clinical & Experimental Medicine
College of Medical & Dental Sciences
University of Birmingham
3rd Floor
Birmingham Women's Foundation Trust
Edgbaston
Birmingham
B15 2TG
United Kingdom
+44 (0)121 627 2775
kmkismail@aol.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0158108052

Study information

Scientific title

The REPAIR Study - Recognition and Expertise in the Prevention of Anal Incontinence from Ruptured Sphincter

Acronym

Study hypothesis

Which method of surgical repair for 3rd and 4th degree obstetric anal sphincter injury results in the better outcome (the overlap method or the juxtaposition method), in terms of the incidence of anal incontinence at 12 months postpartum?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Urological and Genital Diseases: Anal incontinence

Intervention

The proposed trial is a conventional randomised controlled trial of surgical method in the management of an infrequent complication of childbirth that nevertheless blights the lives of many thousands of women in the UK, and more worldwide. The team also hope to be able to draw conclusions about the impact on outcome that arises from the individual skill of the clinician undertaking the repair.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Anal incontinence at 1 year after repair.

Secondary outcome measures

Quality of life 1 year after repair.

Overall trial start date

01/10/2002

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

All women with complete obstetric anal sphincter rupture (3rd or 4th degree perineal tear) where informed consent is given and an authorised clinician is available to perform or supervise the repair. Women who have had previous surgery for obstetric repair or anal fistula will be excluded, as will those who refuse or withdraw their consent.

Participant type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

Not provided at time of registration (recruitment completed)

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/10/2002

Recruitment end date

31/12/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Birmingham
Birmingham
B15 2TG
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Charity

Funder name

North Staffordshire Medical Institute

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes