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Quality Initiative in Rectal Cancer (QIRC) Trial

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ClinicalTrials.gov Identifier: NCT00182130
Recruitment Status : Unknown
Verified July 2005 by McMaster University.
Recruitment status was:  Active, not recruiting
First Posted : September 16, 2005
Last Update Posted : September 16, 2005
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Rectal Cancer Procedure: Quality Initiative in Rectal Cancer (QIRC) strategy

Detailed Description:

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 691 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: Quality Initiative in Rectal Cancer (QIRC) Trial
Study Start Date : May 2002
Estimated Study Completion Date : June 2007
Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Hospital rate of permanent colostomy
  2. Hospital rate of local recurrence

Secondary Outcome Measures :
  1. Bowel, bladder and sexual function
  2. Quality of life

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00182130

Sponsors and Collaborators
Hamilton Health Sciences Corporation
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Marko Simunovic, MD McMaster University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00182130     History of Changes
Other Study ID Numbers: MCT-50013
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: September 16, 2005
Last Verified: July 2005

Keywords provided by McMaster University:
rectal cancer
physician behaviour
knowledge translation

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases