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 |
| Protocol serial number | N0515071873 |
| Sponsor | Department of Health (UK) |
| Funder | North West London Hospitals NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Endoscopic assessment, symptomatic and reoperation rates. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| 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 sample size at registration | 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
- United Kingdom
- England
Study participating centre
Department of General Surgery
Harrow, Middlesex
HA1 3UJ
United Kingdom
HA1 3UJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
