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Quality Initiative in Rectal Cancer (QIRC) Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2005 by McMaster University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00182130
First received: September 10, 2005
Last updated: NA
Last verified: July 2005
History: No changes posted

September 10, 2005
September 10, 2005
May 2002
Not Provided
  • Hospital rate of permanent colostomy
  • Hospital rate of local recurrence
Same as current
No Changes Posted
  • Bowel, bladder and sexual function
  • Quality of life
Same as current
Not Provided
Not Provided
 
Quality Initiative in Rectal Cancer (QIRC) Trial
Quality Initiative in Rectal Cancer (QIRC) Trial

The Quality initiative in rectal cancer (QIRC) trial will test if a strategy designed to positively influence surgeon practice can decrease hospital rates of permanent colostomy and local tumour recurrence for surgically treated rectal cancer patients.

Approximately 5000 Canadians are annually diagnosed with rectal cancer. For patients undergoing rectal cancer surgery two unfortunate outcomes are permanent colostomy and local tumor recurrence. Research demonstrates that in Ontario, Canada and other parts of the world the standard of care for rectal cancer surgery leaves room for improvement.

This is a multi-center trial that will test if a set of interventions designed to positively influence surgeon practice, titled the Quality Initiative in Rectal Cancer (QIRC) strategy, can improve rates of permanent colostomy and local tumour recurrence for surgically treated rectal cancer patients. Secondary outcomes to be assessed include sexual, bowel, and bladder function, and quality of life. The QIRC strategy consists of a workshop to discuss quality issues in rectal cancer, operative demonstration to demonstrate optimal surgical techniques, the use of opinion leaders, and a postoperative questionnaire designed to prompt surgeons to re-examine their key operative steps. The QIRC strategy is largely designed to teach total mesorectal excision, a new gold standard for rectal cancer surgery that has been shown in non-randomized studies to lower patient rates of permanent colostomy and local tumour recurrence.

Sixteen hospitals across the province of Ontario were allocated by cluster randomization to the QIRC strategy (experimental arm) versus minimal intervention (control arm). All hospitals are high-volume centres - an annual rectal cancer procedure volume of 15 or greater. Hospitals in the control arm represent the normal practice environment. Approximately 700 patients will be assessed. In addition to measuring rates of permanent colostomy and local recurrence of tumour, the study will examine bowel, bladder and sexual function, and overall quality of life among patients.

A positive trial – better results in hospitals that receive the intervention – may suggest that to effectively influence surgeon practice, resource intense approaches are necessary along with active buy-in from the surgical community.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Rectal Cancer
Procedure: Quality Initiative in Rectal Cancer (QIRC) strategy
Not Provided
Simunovic M, Coates A, Goldsmith CH, Thabane L, Reeson D, Smith A, McLeod RS, DeNardi F, Whelan TJ, Levine MN. The cluster-randomized Quality Initiative in Rectal Cancer trial: evaluating a quality-improvement strategy in surgery. CMAJ. 2010 Sep 7;182(12):1301-6. Epub 2010 Aug 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
691
June 2007
Not Provided

Inclusion Criteria:

Hospital inclusion criteria:

1. An Ontario hospital with a procedure volume of 15 or more major rectal cancer resections per year for fiscal years 1996 to 1998.

Patient inclusion criteria:

  1. Consecutive patients at each participating site who underwent major rectal cancer surgery.
  2. 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.

Exclusion Criteria:

-

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00182130
MCT-50013
Not Provided
Not Provided
Hamilton Health Sciences Corporation
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Marko Simunovic, MD McMaster University
McMaster University
July 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP