Comparing Robotics and Laparoscopy With Laparotomy/Open Surgery for Endometrial Cancer (GOC2)
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Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
550 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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