Stapled side-to-side anastomosis versus sutured end-to-end anastomosis following resection for primary or recurrent Crohn's disease
ISRCTN | ISRCTN72500766 |
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DOI | https://doi.org/10.1186/ISRCTN72500766 |
Secondary identifying numbers | MCT-50012 |
- Submission date
- 09/09/2005
- Registration date
- 09/09/2005
- Last edited
- 04/08/2009
- 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 Robin Susan McLeod
Scientific
Scientific
Mount Sinai Hospital
449-600 University Avenue
Toronto
M5G 1X5
Canada
Phone | +1 416-586-8534 |
---|---|
rmcleod@mtsinai.on.ca |
Study information
Study design | Randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | Multicentre randomised controlled trial to compare stapled side-to-side anastomosis with sutured end-to-end anastomosis following resection for primary or recurrent Crohn's disease |
Study acronym | CAST (The Canadian and American Surgical Crohn's Disease Trial) |
Study objectives | Patients having an ileocolonic resection for Crohns Disease will have a lower risk of recurrent disease if they have a wide side-to-side anastomosis compared to a end-to-end anastomosis. |
Ethics approval(s) | Mount Sinai Hospital Research Ethics Board approved on the 28th November 2000 |
Health condition(s) or problem(s) studied | Crohns disease |
Intervention | Group 1: Hand sewn anastomosis Group 2: Stapled anastomosis |
Intervention type | Other |
Primary outcome measure | Severe endoscopic recurrence at one year follow-up. |
Secondary outcome measures | 1. Symptomatic recurrence (up to 24 months after) 2. Post-operative complication rates 3. Operative times |
Overall study start date | 01/01/2002 |
Completion date | 31/07/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 200 |
Key inclusion criteria | 1. Women and men aged greater than 16 years 2. Elective ileocolonic resection 3. Colonoscopy and Small Bowel Endoscopy (SBE) completed with the last 3 years 4. Crohns Disease involving the terminal ileum plus or minus right colonic disease 5. No other sites of involvement with Crohns disease in the Gastrointestinal (GI) tract current or past 6. Willing to return for colonoscopy at 12 months |
Key exclusion criteria | 1. Require emergency surgery 2. Have sites of Crohns involvement elsewhere, except for minimal perianal disease 3. Have had strictureplasties or other resections for Crohns disease performed either at this operation or previously, the exception being resections for fistula disease in bowel not affected by Crohns disease 4. Require a bypass procedure or defunctioning ileostomy during the index procedure 5. Have compromised renal function (serum creatinine level greater than 130 mmol/l or 1.5 mg/l) 6. Prednisone, budesonide, 5-Aminosalicylic Acid (5-ASA) medications, ciprofloxacin, metronidazole, cyclosporin and Anti-Tumour Necrotising Factor (Anti-TNF) and any other medications used to treat Crohns cannot be discontinued postoperatively 7. Are unable or willing to give informed consent and return for a colonoscopy at 12 months |
Date of first enrolment | 01/01/2002 |
Date of final enrolment | 31/07/2005 |
Locations
Countries of recruitment
- Canada
Study participating centre
Mount Sinai Hospital
Toronto
M5G 1X5
Canada
M5G 1X5
Canada
Sponsor information
Mount Sinai Hospital (Toronto) (Canada)
Not defined
Not defined
600 University Avenue
Toronto
M5G 1X5
Canada
Phone | +1 416-586-8348 |
---|---|
mmckenzie@mtsinai.on.ca | |
https://ror.org/05deks119 |
Funders
Funder type
Charity
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-50012)
No information available
Crohns & Colitis Foundation of America (USA)
No information available
Results and Publications
Intention to publish date | |
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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 | 01/05/2009 | Yes | No |