Condition category
Digestive System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
18/07/2014
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 WSL Stebbings

ORCID ID

Contact details

Consultant Surgeon and Coloproctologist
Department of Coloproctology and General Surgery
Norfolk and Norwich University Hospital
Brunswick Road
Norwich
NR1 3SR
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0547102225

Study information

Scientific title

Acronym

Study hypothesis

Do side to side stapled anastomosis reduce the rate of peri-anastomotic recurrence rate following a resection for Crohn's disease as this technique results in a wider anastomotic lumen and less tissue ischaemia at the anastomotic site?

Ethics approval

Not provided at time of registration

Study design

Single-blinded 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

Digestive System: Crohn's disease

Intervention

Patients are randomised to side to side stapled anastomosis, or end to end sutured anastomosis, both of which are current practice.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

31/07/2001

Overall trial end date

31/07/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

30-50 local patients

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

31/07/2001

Recruitment end date

31/07/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Consultant Surgeon and Coloproctologist
Norwich
NR1 3SR
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

East Norfolk and Waveney Research Consortium - Norfolk and Norwich University (UK) Hospital/Norwich PCT

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