Condition category
Digestive System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
20/10/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Alastair Windsor

ORCID ID

Contact details

Department of General Surgery
North West London Hospitals NHS Trust
Northwick Park Hospital
Watford Road
Harrow
Middlesex
HA1 3UJ
United Kingdom
+44 0181 864 3232
alwindsor@aol.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0515071873

Study information

Scientific title

Acronym

Study hypothesis

1. Comparing side to side anastomosis in Crohn's disease, sutured versus stapled.
2. Looking at recurrence rates endoscopically, clinically and reoperation rates.

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Digestive System: Crohn's disease

Intervention

Randomised to either sutured or stapled side to side anastamosis following resection for Crohn's disease. Colonoscopy at 6 months, 1 year, 3 years and 10 years, plus clinical follow up.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Endoscopic assessment, symptomatic and reoperation rates.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

06/03/2000

Overall trial end date

06/03/2010

Reason abandoned

Lack of staff/facilities/resources

Eligibility

Participant inclusion criteria

Assuming a 30% decrease in recurrence for the stapled group, we would hope to recruit 50 patients per group. All over 16 years of age.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

06/03/2000

Recruitment end date

06/03/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of General Surgery
Harrow, Middlesex
HA1 3UJ
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

North West London Hospitals NHS Trust (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