Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
14/03/2014
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

Mr William Woods

ORCID ID

Contact details

Worthing & Southlands Hospitals NHS Trust
Worthing Hospital
Lyndhurst Road
Worthing
West Sussex
BN11 2DH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0283122687

Study information

Scientific title

Acronym

Study hypothesis

Is there any difference in terms of complication rate or ease of use with three of the commonly used sutures for stoma formation?

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

Condition

Surgery: Laparotomy

Intervention

This is a single centre prospective randomized controlled trial comparing the complication rates of vicryl, polydioxanone suture (PDS) or biosyn.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Primary outcome measures are numbers of complications.

Secondary outcome measures

Length of hospital stay and time to independence in managing the stoma.

Overall trial start date

16/10/2002

Overall trial end date

30/10/2006

Reason abandoned

Eligibility

Participant inclusion criteria

90 consenting patients due to undergo a laparotomy will be prospectively randomized into three groups.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

90

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

16/10/2002

Recruitment end date

30/10/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Worthing & Southlands Hospitals NHS Trust
Worthing, West Sussex
BN11 2DH
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

Government

Funder name

Sussex NHS Research Consortium (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

Publication citations

Additional files

Editorial Notes