Condition category
Pregnancy and Childbirth
Date applied
01/09/2005
Date assigned
01/09/2005
Last edited
10/09/2012
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 Scott Alexander Farrell

ORCID ID

Contact details

IWK Health Center
5980 University Ave.
Room 6039
Halifax
Nova Scotia
B3J 3G9
Canada
+1 902 470 6768
scott.farrell@iwk.nshealth.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-41547

Study information

Scientific title

Acronym

Study hypothesis

When overlapping surgical repair of third and fourth degree obstetrical lacerations of the external anal sphincter is compared to the standard end-to-end method, it will result in superior symptomatic, anatomical and functional outcomes.

Ethics approval

Ethics approval received from IWK Health Centre Research Ethics Board on the 15th April 2005.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Third or Fourth degree tear of the External Anal Sphincter (EAS) at childbirth.

Intervention

Two arms:
1. Traditional end-to-end repair of the EAS
2. Overlapping repair of the EAS

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Rate of flatal incontinence at 6 months post repair.

Secondary outcome measures

1. Rate of fecal incontinence at 6 months post repair
2. Integrity of EAS by endoanal ultrasound
3. Function of EAS by anal manometry
4. Quality of life by validated QOL measure
5. Post-operative complications

Overall trial start date

01/10/2000

Overall trial end date

30/09/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Complete third or fourth degree tear of the External Anal Sphincter
2. Aged 18 - 49 years old, female

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

150

Participant exclusion criteria

1. Previous 3rd or 4th degree tear
2. Significant history of anal incontinence
3. Inflammatory bowel disease or other gastrointestinal condition which might affect functional outcome

Recruitment start date

01/10/2000

Recruitment end date

30/09/2003

Locations

Countries of recruitment

Canada

Trial participating centre

IWK Health Center
Halifax, Nova Scotia
B3J 3G9
Canada

Sponsor information

Organisation

Dalhousie University (Nova Scotia) (Canada)

Sponsor details

1236 Henry Street
Halifax
Nova Scotia
B3H 3J5
Canada

Sponsor type

University/education

Website

http://www.dal.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-41547)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Nova Scotia Health Research Foundation (Canada)

Alternative name(s)

NSHRF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Canada

Funder name

Dalhousie Medical Research Foundation (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Atlee Foundation (UK)

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

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20567163
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22955309

Publication citations

  1. Results

    Farrell SA, Gilmour D, Turnbull GK, Schmidt MH, Baskett TF, Flowerdew G, Fanning CA, Overlapping compared with end-to-end repair of third- and fourth-degree obstetric anal sphincter tears: a randomized controlled trial., Obstet Gynecol, 2010, 116, 1, 16-24, doi: 10.1097/AOG.0b013e3181e366ef.

  2. Results

    Farrell SA, Flowerdew G, Gilmour D, Turnbull GK, Schmidt MH, Baskett TF, Fanning CA, Overlapping compared with end-to-end repair of complete third-degree or fourth-degree obstetric tears: three-year follow-up of a randomized controlled trial., Obstet Gynecol, 2012, 120, 4, 803-808, doi: 10.1097/AOG.0b013e31826ac4bb.

Additional files

Editorial Notes