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Open Access Study protocol

The Quality Initiative in Rectal Cancer (QIRC) trial: study protocol of a cluster randomized controlled trial in surgery

Marko Simunovic123*, Charles Goldsmith24, Lehana Thabane24, Robin McLeod5, Franco DeNardi6, Timothy J Whelan237 and Mark N Levine237

Author Affiliations

1 Department of Surgery, McMaster University, St. Joseph's Healthcare, G838-50 Charlton Ave. East, Hamilton, Ontario, L8N 4A6, Canada

2 Department of Clinical Epidemiology and Biostatistics, Faculty of Health Sciences, McMaster University, 1200 Main St. W., Hamilton, Ontario, L8N 3Z5, Canada

3 Juravinski Cancer Centre, 699 Concession St., Hamilton, Ontario, L8V 5C2, Canada

4 Centre for Evaluation of Medicines, Biostatistics Unit, St. Joseph's Healthcare, 50 Charlton Avenue East, 3rd Floor Martha, Room H325, Hamilton, Ontario, L8N 4A6, Canada

5 Division of General Surgery, Mount Sinai Hospital, 600 University Avenue, Toronto, Ontario, M5G 1X5, Canada

6 Department of Pathology and Molecular Medicine, McMaster University, Henderson General Hospital, 711 Concession Street, Hamilton, Ontario, L8V 1C3, Canada

7 Department of Oncology, Faculty of Health Sciences, McMaster University, 1200 Main St. W., Hamilton, Ontario, L8N 3Z5, Canada

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BMC Surgery 2008, 8:4  doi:10.1186/1471-2482-8-4

Published: 15 February 2008

Abstract

Background

Two unfortunate outcomes for patients treated surgically for rectal cancer are placement of a permanent colostomy and local tumor recurrence. Total mesorectal excision is a new technique for rectal cancer surgery that can lead to improved patient outcomes. We describe a cluster randomized controlled trial that is testing if the above patient outcomes can be improved through a knowledge translation strategy called the Quality Initiative in Rectal Cancer (QIRC) strategy. The strategy is designed to optimize the use of total mesorectal excision techniques.

Methods and Design

Hospitals were randomized to the QIRC strategy (experimental group) versus normal practice environment (control group). Participating hospitals, and the respective surgeon group operating in them, are from Ontario, Canada and have an annual procedure volume for major rectal cancer resections of 15 or greater. Patients were eligible if they underwent major rectal surgery for a diagnosis of primary rectal cancer. The surgeon-directed QIRC interventions included a workshop, use of opinion leaders, operative demonstrations, a post-operative questionnaire, and, audit and feedback. For an operative demonstration participating surgeons invited a study team surgeon to assist them with a case of rectal cancer surgery. The intent was to demonstrate total mesorectal excision techniques. Control arm surgeons received no intervention. Sample size calculations were two-sided, considered the clustering of data at the hospital level, and were driven by requirements for the outcome local recurrence. To detect an improvement in local recurrence from 20% to 8% with confidence we required 16 hospitals and 672 patients – 8 hospitals and 336 patients in each arm. Outcomes data are collected via chart review for at least 30 months after surgery. Analyses will use an intention-to-treat principle and will consider the clustering of data. Data collection will be complete by the end of 2007.

Discussion

Lower rates of permanent colostomy and local tumour recurrence in the intervention arm would suggest the QIRC strategy is efficacious. The strategy may act as a template for efforts to improve surgical quality in other areas and will contribute to knowledge on influencing surgeon practice.

Trial registration

Current Controlled Trials ISRCTN78363167