The Canadian Colorectal Clinical Trials Network needs your help to keep Canadian surgeons aware and participating in our trials. We are asking you to email us at cscrs@CSCRS.ca with your study titles and single paragraph descriptions of your study protocols. The brief study descriptions will be published here and in the quarterly newsletter of the CSCRS. A second information session of Canadian clinical colorectal trials network was held at the Canadian Surgery Forum in Quebec City.
CSCRS Clinical Trials Group CSF Quebec City 2015
CSF Quebec City 2015
Terry Phang
Title: A Multicentre Randomized Controlled Trial of the Use of Extended Peri-Operative Low Molecular Weight Heparin to Improve Cancer Specific Survival Following Surgical Resection of Colorectal Cancer – PERIOP-01
Summary: This is a Phase III open label randomized controlled trial of prophylactic LMWH (tinzaparin 4,500 IU subcutaneous daily injection) beginning at randomization (within 6 weeks of surgery) and continuing for 56 days post-operatively to assess the efficacy of extended peri-operative thromboprophylaxis to increase Disease Free Survival in participants with resectable colorectal cancer. The trial will also assess the safety of extended peri-operative thromboprophylaxis using tinzaparin and evaluate the pro-metastatic mechanisms of surgery and the antimetastatic mechanisms of LMWH in participants undergoing surgical resection for colorectal cancer. For more information please contact Rebecca Auer rauer@toh.on.ca
Title: Pan-Canadian Colorectal Cancer Consortium
Summary: The objective of the Pan-Canadian Colorectal Consortium (C4) is to establish a molecular-based approach to translational cancer care that will improve the outcome of patients with colorectal cancer (CRC) by: i) Improving the impact of early diagnosis, decreasing mortality and the cost of managing CRC through targeted screening of families stratified by risk (Screening Axis); ii) Improving the life expectancy and reducing the cost of the management of advanced CRC through the study of drug resistant metastatic disease and the development of a biomarker panel to predict drug resistance (Therapeutic Axis). The C4 has established a pan-Canadian multidisciplinary and inter-institutional network that embraces the entire spectrum of CRC care, leading to state-of-the-art diagnostics and therapeutics. For more information contact Steve Gallinger steven.gallinger@uhn.on.ca
Title: Prophylactic tamsulosin in prevention of post-operative urinary retention in men after transanal endoscopic microsurgery: A multicenter randomized, double-blind, placebo-controlled clinical trial
Summary: In 2013, the retrospective study, by Laliberte and al. of the 178 first patients operated with transanal endoscopic microsurgery (TEM) at the Saint-Francois-d’Assise Hospital in Quebec City showed that 19% presented a post-operative urinary retention. No risk factor was statistically significant and the majority were treated as outpatients. In December 2014, the updated data revealed a 25% incidence of post-operative urinary retention in men only. The aim of this study is to reduce this incidence in men and limit the interventions and hospitalizations related to this complication. We will compare a 7-day prophylactic therapy of tamsulosin capsules 0.4 mg once daily to a placebo. For more information contact Claudia Morin claudya.morin.1@ulaval.ca
Title: Less May be More: Loop Ileostomy with Colonic Lavage for Fulminant Clostridium difficile Colitis – A Prospective National Multi-Center Cohort Study
Summary: This is a national multicenter registry to assess an innovative minimally-invasive colon-preserving operation for fulminant Clostridium difficile colitis. The standard of care for fulminant C. difficile colitis is a timely total abdominal colectomy with end ileostomy (TAC); however despite this intervention mortality rates remain unacceptably high (up to 50%) The objective of this study is to determine if loop ileostomy and colonic lavage reduces 30-day all-cause mortality compared to the current standard of care for fulminant C. difficile colitis, total abdominal colectomy with end ileostomy. To test the hypothesis of an absolute risk reduction in mortality of 22% with loop ileostomy and colonic lavage, we will accrue 63 patients in each arm over 2 years. Currently, 20 centers across Canada are participating in the study. This trial assesses a potentially superior alternative for fulminant C.difficile colitis that may impact future treatment; and this multicenter registry study design allows for timely prospective evaluation that will reflect real-life practice and yield generalizable results. Please contact our Research associate Ms. Marie Demian, MSc at mariedemian@gmail.com or the Principal Investigator Marylise Boutros, MD at mboutros@jgh.mcgill.ca if your center would like to participate – we would be glad to facilitate study initiation at your site.
Title: TEMPEST2: A Randomized Controlled Trial of the Effect of Metronidazole on Postoperative Pain and Early Complications after Transanal Endoscopic Microsurgery
Summary: This is a multicentre randomized, double-blind, placebo controlled trial (RCT) to evaluate the effectiveness of metronidazole treatment in reducing postoperative pain and early complications after transanal endoscopic microsurgery (TEM). The rationale for this study includes: (1) evidence supporting the use of metronidazole in other surgical populations; (2) lack of evidence in patients undergoing TEM for removal of rectal tumours. The primary outcome for this study is postoperative pain as measured by the participant on a visual analogue scale (VAS). Secondary outcomes include total analgesic consumption and complications within 30 days of surgery. Participants will be randomized to receive either 7 days of metronidazole (500mg TID) or 7 days of placebo postoperatively, stratified by participating site and distance of tumour from anal verge. To show a clinically and statistically significant difference in the primary outcome, a total of 128 patients (64 participants per arm) will need to be recruited. If interested in becoming a participating site, please contact larwilliams@toh.on.ca.