Condition category
Digestive System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
21/02/2012
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 MRB Keighley

ORCID ID

Contact details

GI Surgery
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0265041723

Study information

Scientific title

Acronym

Study hypothesis

Whether a wider stapled anastomosis is associated with a lower recurrence rate than a sutured end to end anastomosis.

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

Not Specified

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

Prospective randomized trial to compare stapled "functional end to end anastomosis" (side to side in reality) with sutured end to end anastomosis in patients having:
a. Resection of ileocaecal Crohn's disease
b. Resection of recurrent ileocaecal Crohn's disease.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Lower recurrence rate.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2000

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with ileocolonic Crohn's disease needing a resection.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2000

Recruitment end date

01/01/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

GI Surgery
Birmingham
B15 2TH
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

University Hospital Birmingham 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

1. 1999 results in http://www.ncbi.nlm.nih.gov/pubmed/10466883

Publication citations

  1. Results

    Yamamoto T, Bain IM, Mylonakis E, Allan RN, Keighley MR, Stapled functional end-to-end anastomosis versus sutured end-to-end anastomosis after ileocolonic resection in Crohn disease., Scand. J. Gastroenterol., 1999, 34, 7, 708-713.

Additional files

Editorial Notes