Comparing Robotics and Laparoscopy With Laparotomy/Open Surgery for Endometrial Cancer (GOC2)

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

Study Overview

• Status: Completed
• Conditions: Cancer of the Endometrium

• Study Type: Observational
• Enrollment (Actual): 550

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • Ontario
    • Kingston, Ontario, Canada, K7L5P9
      • Kingston General Hospital
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Hospital
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Regional Cancer Centre
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital
    • Montreal, Quebec, Canada, H2L 4M1
      • Hopital Notre-Dame du CHUM
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Saskatoon Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

New patients in the gynecologic oncology clinic will be offered the surgery that is deemed appropriate by their individual surgeon based on the patient's medical and surgical histories, type of malignancy, and the surgeon's expertise in open surgery, laparoscopy and/or robotic surgery.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Laparoscopic surgery
Laparotomy (open surgery)
Robotic assisted surgery

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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Marcus Q Bernardini, MD MSc FRCSC, Princess Margaret Hospital, University Health Network

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: October 19, 2011
• First Submitted That Met QC Criteria: November 24, 2011
• First Posted (Estimate): November 29, 2011

Study Record Updates

• Last Update Posted (Actual): August 28, 2020
• Last Update Submitted That Met QC Criteria: August 27, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Robotic surgery; Laparoscopy; Laparotomy; Open Surgery
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endometrial Neoplasms
• Other Study ID Numbers: 11-0447-CE