Do side to side stapled anastomosis reduce the rate of perianastomotic recurrence in Crohn's Disease? A single-blinded prospective randomised trial
| ISRCTN | ISRCTN73474172 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73474172 |
| Protocol serial number | N0547102225 |
| Sponsor | Department of Health (UK) |
| Funder | East Norfolk and Waveney Research Consortium - Norfolk and Norwich University (UK) Hospital/Norwich PCT |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 18/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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 WSL Stebbings
Scientific
Scientific
Consultant Surgeon and Coloproctologist
Department of Coloproctology and General Surgery
Norfolk and Norwich University Hospital
Brunswick Road
Norwich
NR1 3SR
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-blinded randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | Do side to side stapled anastomosis reduce the rate of peri-anastomotic recurrence rate following a resection for Crohn's disease as this technique results in a wider anastomotic lumen and less tissue ischaemia at the anastomotic site? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Digestive System: Crohn's disease |
| Intervention | Patients are randomised to side to side stapled anastomosis, or end to end sutured anastomosis, both of which are current practice. |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 50 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 31/07/2001 |
| Date of final enrolment | 31/07/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Consultant Surgeon and Coloproctologist
Norwich
NR1 3SR
United Kingdom
NR1 3SR
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
