Randomized controlled trial to compare stapled functional end to end anastomosis against sutured end to end anastomosis following ileocolonic resection for terminal ileal Crohn's disease or recurrence of Crohn's disease in the terminal ileum
| ISRCTN | ISRCTN64225868 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64225868 |
| Secondary identifying numbers | N0265041723 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 21/02/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr MRB Keighley
Scientific
Scientific
GI Surgery
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | Whether a wider stapled anastomosis is associated with a lower recurrence rate than a sutured end to end anastomosis. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Lower recurrence rate. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2000 |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Patients with ileocolonic Crohn's disease needing a resection. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
GI Surgery
Birmingham
B15 2TH
United Kingdom
B15 2TH
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
University Hospital Birmingham NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/1999 | Yes | No |
