Quality Initiative in Rectal Cancer trial

ISRCTN	ISRCTN78363167
DOI	https://doi.org/10.1186/ISRCTN78363167
ClinicalTrials.gov number	NCT00182130
Secondary identifying numbers	MCT-50013

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Marko Simunovic
Scientific

Juravinski Cancer Centre
699 Concession Street
Hamilton, ON
L8V 5C2
Canada

Phone	+1 905 575 6365
Email	marko.simunovic@hrcc.on.ca

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	QIRC
Study objectives	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(s)	Ethics approval received from the McMaster University Research Ethics Board on the 30th August 2001.
Health condition(s) or problem(s) studied	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
Primary outcome measure	1. Rate of permanent colostomy 2. Rate of local recurrence
Secondary outcome measures	1. Bowel, bladder and sexual function 2. Quality of life
Overall study start date	01/05/2002
Completion date	31/05/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	672 (total patients accrued = 1015)
Key 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
Key exclusion criteria	Does not comply with the above criteria.
Date of first enrolment	01/05/2002
Date of final enrolment	31/05/2006

Juravinski Cancer Centre

Hamilton, ON
L8V 5C2
Canada

Juravinski Cancer Centre (Canada)
Government

699 Concession Street
Hamilton, Ontario
L8V 5C2
Canada

"ROR"	https://ror.org/02cwjh447

Research organisation

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

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	15/02/2008	Yes	No
Results article	results	01/12/2013	Yes	No
Results article	results	01/12/2013	Yes	No