Contact information
Type
Scientific
Primary contact
Dr Robin Susan McLeod
ORCID ID
Contact details
Mount Sinai Hospital
449-600 University Avenue
Toronto
M5G 1X5
Canada
+1 416-586-8534
rmcleod@mtsinai.on.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-50012
Study information
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
Acronym
CAST (The Canadian and American Surgical Crohn's Disease Trial)
Study hypothesis
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
Mount Sinai Hospital Research Ethics Board approved on the 28th November 2000
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Crohns disease
Intervention
Group 1: Hand sewn anastomosis
Group 2: Stapled anastomosis
Intervention type
Other
Phase
Not Applicable
Drug names
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 trial start date
01/01/2002
Overall trial end date
31/07/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant 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
Recruitment start date
01/01/2002
Recruitment end date
31/07/2005
Locations
Countries of recruitment
Canada
Trial participating centre
Mount Sinai Hospital
Toronto
M5G 1X5
Canada
Sponsor information
Organisation
Mount Sinai Hospital (Toronto) (Canada)
Sponsor details
600 University Avenue
Toronto
M5G 1X5
Canada
+1 416-586-8348
mmckenzie@mtsinai.on.ca
Sponsor type
Not defined
Website
Funders
Funder type
Charity
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-50012)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Crohns & Colitis Foundation of America (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19502857
Publication citations
-
Results
McLeod RS, Wolff BG, Ross S, Parkes R, McKenzie M, , Recurrence of Crohn's disease after ileocolic resection is not affected by anastomotic type: results of a multicenter, randomized, controlled trial., Dis. Colon Rectum, 2009, 52, 5, 919-927, doi: 10.1007/DCR.0b013e3181a4fa58.