Comparing Robotics and Laparoscopy With Laparotomy/Open Surgery for Endometrial Cancer (GOC2)
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|ClinicalTrials.gov Identifier: NCT01480999|
Recruitment Status : Active, not recruiting
First Posted : November 29, 2011
Last Update Posted : May 11, 2016
The use of robotic surgery in the management of gynecologic cancers has increased exponentially in the United States since the implementation of technology in 2005. In Canada, access to the system is limited because of a lack of government funding. The government has been reluctant to fund this technology because robust data, on the true impact to patient care, is lacking.
This project will prospectively examine outcomes of women, with early stage endometrial cancer, treated surgically. Open surgery will be compared to minimally invasive surgery (MIS) which will include conventional laparoscopy and robotic surgery. The data collected will include detailed assessment of surgical data, peri-operative events, quality of life analysis, health economic evaluation and evaluation of MIS rates.
|Condition or disease|
|Cancer of the Endometrium|
|Study Type :||Observational|
|Actual Enrollment :||550 participants|
|Official Title:||A Prospective Study Evaluating Surgical and Quality of Life Outcomes in Robotics and Laparoscopy Compared to Laparotomy in Early Stage Endometrial Cancer|
|Study Start Date :||November 2011|
|Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||December 2016|
|Laparotomy (open surgery)|
|Robotic assisted surgery|
- Surgical Outcomes [ Time Frame: 6 months ]Intraoperative complications as well as perioperative (time to discharge from hospital), early postoperative (<4 weeks) and long-term morbidity (4 weeks to 6 months)
- Quality of Life Outcomes [ Time Frame: 6 months ]Validated quality of life questionnaires to assess the time it takes a patient to return to normal activity or work, the effect of surgery on their day-to-day living, pain, body image, sexuality, social life as well as about the costs associated with their surgery.
- Cost-effectiveness [ Time Frame: 6 months ]Compare cost-effectiveness between MIS (minimally invasive surgery) and open surgery for early stage endometrial cancer, by evaluating lengths of hospital stay, in hospital costs and out of hospital costs
- Evolution of MIS rates [ Time Frame: Prior to recruitment of the first patient and every 6 months for the duration of the study ]Determine the evolution of MIS rates at each centre participating in this study, including the number of surgeons offering MIS, and the number of patients offered MIS. Evaluate whether the introduction of robotic surgery increases the proportion of patients undergoing MIS. Compare the characteristics of patients undergoing robotic-assisted, laparoscopic or open surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01480999
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Kingston General Hospital|
|Kingston, Ontario, Canada, K7L5P9|
|Sunnybrook Regional Cancer Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Hopital Notre-Dame du CHUM|
|Montreal, Quebec, Canada, H2L 4M1|
|Jewish General Hospital|
|Montreal, Quebec, Canada, H3T 1E2|
|Saskatoon Cancer Centre|
|Saskatoon, Saskatchewan, Canada, S7N 4H4|
|Principal Investigator:||Marcus Q Bernardini, MD MSc FRCSC||Princess Margaret Hospital - University Health Network|