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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01480999
Recruitment Status : Unknown
Verified May 2016 by University Health Network, Toronto.
Recruitment status was:  Active, not recruiting
First Posted : November 29, 2011
Last Update Posted : May 11, 2016
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease
Cancer of the Endometrium

Study Type : Observational
Actual Enrollment : 550 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study Evaluating Surgical and Quality of Life Outcomes in Robotics and Laparoscopy Compared to Laparotomy in Early Stage Endometrial Cancer
Study Start Date : November 2011
Actual Primary Completion Date : July 2015
Estimated Study Completion Date : December 2016

Laparotomy (open surgery)
Laparoscopic surgery
Robotic assisted surgery

Primary Outcome Measures :
  1. 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)

  2. 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.

  3. 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 Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01480999

Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L5P9
Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada, H2L 4M1
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Canada, Saskatchewan
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
University Health Network, Toronto
Principal Investigator: Marcus Q Bernardini, MD MSc FRCSC Princess Margaret Hospital - University Health Network

Responsible Party: University Health Network, Toronto Identifier: NCT01480999     History of Changes
Other Study ID Numbers: 11-0447-CE
First Posted: November 29, 2011    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: May 2016

Keywords provided by University Health Network, Toronto:
Open Surgery
Robotic surgery

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female