Quality Initiative in Rectal Cancer (QIRC) Trial

Rectal Cancer Clinical Trial

Official title:

Quality Initiative in Rectal Cancer (QIRC) Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00182130
• Other study ID #: MCT-50013
• Status: Active, not recruiting
• Phase: N/A
• First received: September 10, 2005
• Last updated: September 10, 2005
• Start date: May 2002
• Est. completion date: June 2007

Study information

• Verified date: July 2005
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 691
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Quality Initiative in Rectal Cancer (QIRC) strategy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Canadian Institutes of Health Research (CIHR)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital rate of permanent colostomy
Primary	Hospital rate of local recurrence
Secondary	Bowel, bladder and sexual function
Secondary	Quality of life