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

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.

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Key information

Conditions

Cancer of the Endometrium Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Cross Cancer Institute, Edmonton, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Surgical Outcomes

Time frame: 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

Time frame: 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

Time frame: 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 outcomes

Evolution of MIS rates

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: GOC2

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2020
First posted: Nov 29, 2011
Registry last updated: Aug 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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