Stapled side-to-side anastomosis versus sutured end-to-end anastomosis following resection for primary or recurrent Crohn's disease

ISRCTN	ISRCTN72500766
DOI	https://doi.org/10.1186/ISRCTN72500766
Protocol serial number	MCT-50012
Sponsor	Mount Sinai Hospital (Toronto) (Canada)
Funders	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-50012), Crohns & Colitis Foundation of America (USA)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Robin Susan McLeod
Scientific

Mount Sinai Hospital
449-600 University Avenue
Toronto
M5G 1X5
Canada

Phone	+1 416-586-8534
Email	rmcleod@mtsinai.on.ca

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	Severe endoscopic recurrence at one year follow-up.
Key secondary outcome measure(s)	1. Symptomatic recurrence (up to 24 months after) 2. Post-operative complication rates 3. Operative times
Completion date	31/07/2005

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Mount Sinai Hospital

Toronto
M5G 1X5
Canada

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2009		Yes	No