Comparing Robotics and Laparoscopy With Laparotomy/Open Surgery for Endometrial Cancer (GOC2)

• Surgical Outcomes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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

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.

New patients in the gynecologic oncology clinic will be offered the surgery that is deemed appropriate by their individual surgeon based on the patient's medical and surgical histories, type of malignancy, and the surgeon's expertise in open surgery, laparoscopy and/or robotic surgery.

• Laparotomy (open surgery)
• Laparoscopic surgery
• Robotic assisted surgery

Inclusion Criteria:

• Any type of histologically confirmed early stage (stage 1 or 2) cancer of the endometrium
• Adequate bone marrow, renal and hepatic function (Aust - WBC >3.0 x 109 cells/L, Platelets >100x109 cells/L, Creatinine <180 µmmol/L, Bilirubin <1.5 x normal, AST <3 x normal)
• 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