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Quality Initiative in Rectal Cancer (QIRC) Trial

Open (Enrolling)
Rectal Cancer

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Trial Information

Quality Initiative in Rectal Cancer (QIRC) Trial

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

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.

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

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:


Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Outcome Measure:

Hospital rate of permanent colostomy

Principal Investigator

Marko Simunovic, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

McMaster University


Canada: Health Canada

Study ID:




Start Date:

May 2002

Completion Date:

June 2007

Related Keywords:

  • Rectal Cancer
  • rectal cancer
  • surgery
  • physician behaviour
  • knowledge translation
  • Rectal Neoplasms