Cancer of the Endometrium
Conditions
Keywords
Laparotomy, Open Surgery, Laparoscopy, Robotic surgery
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.
Interventions
None listed
Sponsors
University Health Network, Toronto
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Outcome results
None listed