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
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

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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleMulticentre 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 acronymCAST (The Canadian and American Surgical Crohn's Disease Trial)
Study objectivesPatients having an ileocolonic resection for Crohn’s 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) studiedCrohn’s disease
InterventionGroup 1: Hand sewn anastomosis
Group 2: Stapled anastomosis
Intervention typeOther
Primary outcome measureSevere endoscopic recurrence at one year follow-up.
Secondary outcome measures1. Symptomatic recurrence (up to 24 months after)
2. Post-operative complication rates
3. Operative times
Overall study start date01/01/2002
Completion date31/07/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants200
Key inclusion criteria1. 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. Crohn’s Disease involving the terminal ileum plus or minus right colonic disease
5. No other sites of involvement with Crohn’s disease in the Gastrointestinal (GI) tract current or past
6. Willing to return for colonoscopy at 12 months
Key exclusion criteria1. Require emergency surgery
2. Have sites of Crohn’s involvement elsewhere, except for minimal perianal disease
3. Have had strictureplasties or other resections for Crohn’s disease performed either at this operation or previously, the exception being resections for fistula disease in bowel not affected by Crohn’s 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 Crohn’s cannot be discontinued postoperatively
7. Are unable or willing to give informed consent and return for a colonoscopy at 12 months
Date of first enrolment01/01/2002
Date of final enrolment31/07/2005

Locations

Countries of recruitment

  • Canada

Study participating centre

Mount Sinai Hospital
Toronto
M5G 1X5
Canada

Sponsor information

Mount Sinai Hospital (Toronto) (Canada)
Not defined

600 University Avenue
Toronto
M5G 1X5
Canada

Phone +1 416-586-8348
Email mmckenzie@mtsinai.on.ca
ROR logo "ROR" 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

Crohn’s & Colitis Foundation of America (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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