Quality Initiative in Rectal Cancer (QIRC) Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

691 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rectal Cancer

Keywords

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rectal cancer surgery physician behaviour knowledge translation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

ECT

Blinding Strategy

NONE

Interventions

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Quality Initiative in Rectal Cancer (QIRC) strategy

Intervention Type PROCEDURE

Eligibility Criteria

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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.

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

\-

Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Marko Simunovic, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

References

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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. doi: 10.1503/cmaj.091883. Epub 2010 Aug 9.

Reference Type DERIVED

PMID: 20696797 (View on PubMed)

Other Identifiers

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MCT-50013

Identifier Type: -

Identifier Source: org_study_id