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

Study Overview
=================
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.

Official Title
-----------------
A Prospective Study Evaluating Surgical and Quality of Life Outcomes in Robotics and Laparoscopy Compared to Laparotomy in Early Stage Endometrial Cancer

Conditions
-----------------
Cancer of the Endometrium

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Laparotomy (open surgery)<br> | |
| Laparoscopic surgery<br> | |
| Robotic assisted surgery<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Outcomes | Intraoperative complications as well as perioperative (time to discharge from hospital), early postoperative (<4 weeks) and long-term morbidity (4 weeks to 6 months) | 6 months | 
| Quality of Life Outcomes | 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. | 6 months | 
| Cost-effectiveness | 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of MIS rates | 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. | Prior to recruitment of the first patient and every 6 months for the duration of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparotomy, Open Surgery, Laparoscopy, Robotic surgery