A randomised controlled trial comparing stapled to sutured side to side anastomosis in Crohn's disease
| ISRCTN | ISRCTN40167533 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40167533 |
| Secondary identifying numbers | N0515071873 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 20/10/2010
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Alastair Windsor
Scientific
Scientific
Department of General Surgery
North West London Hospitals NHS Trust
Northwick Park Hospital
Watford Road
Harrow, Middlesex
HA1 3UJ
United Kingdom
| Phone | +44 0181 864 3232 |
|---|---|
| alwindsor@aol.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Endoscopic assessment, symptomatic and reoperation rates. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 06/03/2000 |
| Completion date | 06/03/2010 |
| Reason abandoned (if study stopped) | Lack of staff/facilities/resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 100 |
| Key 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. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 06/03/2000 |
| Date of final enrolment | 06/03/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of General Surgery
Harrow, Middlesex
HA1 3UJ
United Kingdom
HA1 3UJ
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
North West London Hospitals 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 |
