Comparing Robotics and Laparoscopy With Laparotomy/Open Surgery for Endometrial Cancer

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Any type of histologically confirmed early stage (stage 1 or 2) cancer of the endometrium
ECOG Performance status of 0-1
Suitable candidate for surgery
Signed approved informed consent
Female, 18 years of age or older
Pre-operative health is graded as ASA I-III
Patients able to complete baseline questions either on their own or with assistance
Patient willing to comply with scheduled visits

Exclusion Criteria

Major abdominal surgery, chemotherapy or radiation within 3 months before the baseline visit
Evidence of diffuse peritoneal carcinomatosis by imaging or clinical exam
Unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator)
Patients who are breastfeeding or become pregnant during the study

Primary Outcome Measures

Name	Time	Method
Surgical Outcomes	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	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	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

Secondary Outcome Measures

Name	Time	Method
Evolution of MIS rates	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.

Locations (7): Jewish General Hospital
🇨🇦
Montreal, Quebec, Canada
Hopital Notre-Dame du CHUM
🇨🇦
Montreal, Quebec, Canada
Saskatoon Cancer Centre
🇨🇦
Saskatoon, Saskatchewan, Canada
Cross Cancer Institute
🇨🇦
Edmonton, Alberta, Canada
Kingston General Hospital
🇨🇦
Kingston, Ontario, Canada
Sunnybrook Regional Cancer Centre
🇨🇦
Toronto, Ontario, Canada
Princess Margaret Hospital
🇨🇦
Toronto, Ontario, Canada

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