Overview

This trial is active, not recruiting.

Condition cancer of the endometrium
Sponsor University Health Network, Toronto
Start date November 2011
End date July 2015
Trial size 550 participants
Trial identifier NCT01480999, 11-0447-CE

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
Surgical Outcomes
time frame: 6 months
Quality of Life Outcomes
time frame: 6 months
Cost-effectiveness
time frame: 6 months

Secondary Outcomes

Measure
Evolution of MIS rates
time frame: Prior to recruitment of the first patient and every 6 months for the duration of the study

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title A Prospective Study Evaluating Surgical and Quality of Life Outcomes in Robotics and Laparoscopy Compared to Laparotomy in Early Stage Endometrial Cancer
Principal investigator Marcus Q Bernardini, MD MSc FRCSC
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.