Condition category
Digestive System
Date applied
09/09/2005
Date assigned
09/09/2005
Last edited
04/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 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

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

Crohn’s disease

Intervention

Group 1: Hand sewn anastomosis
Group 2: Stapled anastomosis

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

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. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. 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

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

Crohn’s & 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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19502857

Publication citations

  1. 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.

Additional files

Editorial Notes