Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182130
Status:
UNKNOWN
Last Update Posted:
2005-09-16
First Post:
2005-09-10
Brief Title:
Quality Initiative in Rectal Cancer QIRC Trial
Sponsor:
Hamilton Health Sciences Corporation
Organization:
McMaster University
Study Overview
Official Title:
Quality Initiative in Rectal Cancer QIRC Trial
Status:
UNKNOWN
Status Verified Date:
2005-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None