Condition category
Cancer
Date applied
18/11/2004
Date assigned
15/08/2005
Last edited
29/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marko Simunovic

ORCID ID

Contact details

Juravinski Cancer Centre
699 Concession Street
Hamilton
ON
L8V 5C2
Canada
+1 905 575 6365
marko.simunovic@hrcc.on.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00182130

Protocol/serial number

MCT-50013

Study information

Scientific title

Acronym

QIRC

Study hypothesis

To test if the quality initiative in rectal cancer strategy, which is designed to positively influence surgeon practice, can decrease hospital rates of permanent colostomy and local tumour recurrence for surgically treated rectal cancer patients.

Ethics approval

Ethics approval received from the McMaster University Research Ethics Board on the 30th August 2001.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Rectal cancer

Intervention

Surgeons in the 8 hospitals allocated to the experimental arm will be exposed to the QIRC strategy. The strategy includes a workshop, operative demonstrations, use of opinion leaders, audit and feedback, and a post-operative questionnaire. Hospitals in the control arm represent the normal practice environment.

Accrual closed effective on the 11th December, 2004 (we are now conducting patient follow up as per protocol; minimum 30 month follow up; study follow up will be completed June 30, 2007).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Rate of permanent colostomy
2. Rate of local recurrence

Secondary outcome measures

1. Bowel, bladder and sexual function
2. Quality of life

Overall trial start date

01/05/2002

Overall trial end date

31/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Hospital criteria:
An Ontario hospital with a procedure volume of 15 or more major rectal cancer resections per year for fiscal years 1996 to 1998.

Patient criteria:
1. Persons of either sex, age groups 18 and above
2. Consecutive patients undergoing major rectal cancer surgery
3. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

672 (total patients accrued = 1015)

Participant exclusion criteria

Does not comply with the above criteria.

Recruitment start date

01/05/2002

Recruitment end date

31/05/2006

Locations

Countries of recruitment

Canada

Trial participating centre

Juravinski Cancer Centre
Hamilton, ON
L8V 5C2
Canada

Sponsor information

Organisation

Juravinski Cancer Centre (Canada)

Sponsor details

699 Concession Street
Hamilton
Ontario
L8V 5C2
Canada

Sponsor type

Government

Website

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-50013)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/18279521
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24284154
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24284150

Publication citations

  1. Protocol

    Simunovic M, Goldsmith C, Thabane L, McLeod R, Denardi F, Whelan TJ, Levine MN, The Quality Initiative in Rectal Cancer (QIRC) trial: study protocol of a cluster randomized controlled trial in surgery., BMC Surg, 2008, 8, 4, doi: 10.1186/1471-2482-8-4.

  2. Results

    Francescutti V, Coates A, Thabane L, Goldsmith CH, Levine MN, Simunovic M, Patterns of use and outcomes for radiation therapy in the Quality Initiative in Rectal Cancer (QIRC) trial., Can J Surg, 2013, 56, 6, E148-53.

  3. Results

    Simunovic M, Coates A, Smith A, Thabane L, Goldsmith CH, Levine MN, Uptake of an innovation in surgery: observations from the cluster-randomized Quality Initiative in Rectal Cancer trial., Can J Surg, 2013, 56, 6, 415-421.

Additional files

Editorial Notes