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 |
| Protocol serial number | N0265041723 |
| Sponsor | Department of Health (UK) |
| Funder | University Hospital Birmingham NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Lower recurrence rate. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| 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
- United Kingdom
- England
Study participating centre
GI Surgery
Birmingham
B15 2TH
United Kingdom
B15 2TH
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/1999 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
