Contact information
Type
Scientific
Primary contact
Dr Marko Simunovic
ORCID ID
Contact details
Juravinski Cancer Centre
699 Concession Street
Hamilton
ON
L8V 5C2
Canada
+1 905 575 6365
marko.simunovic@hrcc.on.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00182130
Protocol/serial number
MCT-50013
Study information
Scientific title
Acronym
QIRC
Study hypothesis
To test if the quality initiative in rectal cancer strategy, which is designed to positively influence surgeon practice, can decrease hospital rates of permanent colostomy and local tumour recurrence for surgically treated rectal cancer patients.
Ethics approval
Ethics approval received from the McMaster University Research Ethics Board on the 30th August 2001.
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
Rectal cancer
Intervention
Surgeons in the 8 hospitals allocated to the experimental arm will be exposed to the QIRC strategy. The strategy includes a workshop, operative demonstrations, use of opinion leaders, audit and feedback, and a post-operative questionnaire. Hospitals in the control arm represent the normal practice environment.
Accrual closed effective on the 11th December, 2004 (we are now conducting patient follow up as per protocol; minimum 30 month follow up; study follow up will be completed June 30, 2007).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Rate of permanent colostomy
2. Rate of local recurrence
Secondary outcome measures
1. Bowel, bladder and sexual function
2. Quality of life
Overall trial start date
01/05/2002
Overall trial end date
31/05/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Hospital criteria:
An Ontario hospital with a procedure volume of 15 or more major rectal cancer resections per year for fiscal years 1996 to 1998.
Patient criteria:
1. Persons of either sex, age groups 18 and above
2. Consecutive patients undergoing major rectal cancer surgery
3. Tumor located within 15 cm of anal verge by rigid sigmoidoscopy, or, at or below the level of the sacral promontory at the time of surgery
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
672 (total patients accrued = 1015)
Participant exclusion criteria
Does not comply with the above criteria.
Recruitment start date
01/05/2002
Recruitment end date
31/05/2006
Locations
Countries of recruitment
Canada
Trial participating centre
Juravinski Cancer Centre
Hamilton, ON
L8V 5C2
Canada
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-50013)
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
2008 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/18279521
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24284154
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24284150
Publication citations
-
Protocol
Simunovic M, Goldsmith C, Thabane L, McLeod R, Denardi F, Whelan TJ, Levine MN, The Quality Initiative in Rectal Cancer (QIRC) trial: study protocol of a cluster randomized controlled trial in surgery., BMC Surg, 2008, 8, 4, doi: 10.1186/1471-2482-8-4.
-
Results
Francescutti V, Coates A, Thabane L, Goldsmith CH, Levine MN, Simunovic M, Patterns of use and outcomes for radiation therapy in the Quality Initiative in Rectal Cancer (QIRC) trial., Can J Surg, 2013, 56, 6, E148-53.
-
Results
Simunovic M, Coates A, Smith A, Thabane L, Goldsmith CH, Levine MN, Uptake of an innovation in surgery: observations from the cluster-randomized Quality Initiative in Rectal Cancer trial., Can J Surg, 2013, 56, 6, 415-421.