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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University Health Network, Toronto.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01480999
First received: October 19, 2011
Last updated: November 24, 2011
Last verified: November 2011
  Purpose

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
Cancer of the Endometrium

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Surgical Outcomes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • Evolution of MIS rates [ Time Frame: Prior to recruitment of the first patient and every 6 months for the duration of the study ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1000
Study Start Date: December 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Laparotomy (open surgery)
Laparoscopic surgery
Robotic assisted surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.

Criteria

Inclusion Criteria:

  • Any type of histologically confirmed early stage (stage 1 or 2) cancer of the endometrium
  • Adequate bone marrow, renal and hepatic function (Aust - WBC >3.0 x 109 cells/L, Platelets >100x109 cells/L, Creatinine <180 µmmol/L, Bilirubin <1.5 x normal, AST <3 x normal)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01480999

Contacts
Contact: Marcus Q Bernardini, MD MSc FRCSC 416 946 4501 ext 2668 marcus.bernardini@uhn.ca

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10065
Contact: Elizabeth Jewell, MD       jewelle@mskcc.org   
Principal Investigator: Elizabeth Jewell, MD         
United States, North Carolina
Duke Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Laura Havrilesky, MD       laura.havrilesky@duke.edu   
Principal Investigator: Laura Havrilesky, MD         
Canada, Alberta
Tom Baker Cancer Centre Not yet recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Prafull Ghatage, MD       Prafull.Ghatage@albertahealthservices.ca   
Principal Investigator: Prafull Ghatage, MD         
Cross Cancer Institute Not yet recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Helen Steed, MD       Helen.Steed@albertahealthservices.ca   
Principal Investigator: Helen Steed, MD         
Canada, Ontario
Ottawa Regional Cancer Centre Not yet recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Tien Le, MD       tle@Ottawahospital.on.ca   
Principal Investigator: Tien Le, MD         
Princess Margaret Hospital Not yet recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Marcus Bernardini, MD       marcus.bernardini@uhn.ca   
Sub-Investigator: Sarah Ferguson, MD         
Sub-Investigator: Joan Murphy, MD         
Sub-Investigator: Barry Rosen, MD         
Sunnybrook Regional Cancer Centre Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Lilian Gien, MD       Lilian.Gien@sunnybrook.ca   
Principal Investigator: Lilian Gien, MD         
Canada, Quebec
Hopital Notre-Dame du CHUM Not yet recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Diane Provencher, MD       diane.provencher.chum@ssss.gouv.qc.ca   
Principal Investigator: Diane Provencher, MD         
Jewish General Hospital Not yet recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Walter Gotlieb, MD       walter.gotlieb@mcgill.ca   
Principal Investigator: Walter Gotlieb, MD         
Canada, Saskatchewan
Allan Blair Cancer Centre Not yet recruiting
Regina, Saskatchewan, Canada, S4T 7T1
Contact: Lynn Dwernychuk    (306) 655-0428    lynn.dwernychuk@saskcancer.ca   
Saskatoon Cancer Centre Not yet recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
Contact: Christopher Giede, MD       christopher.giede@usask.ca   
Principal Investigator: Christopher Giede, MD         
Canada
L'Hotel-Dieu de Quebec Not yet recruiting
Quebec, Canada, G1R 2J6
Contact: Marie Plante, MD       marie.plante@crhdq.ulaval.ca   
Principal Investigator: Marie Plante, MD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Marcus Q Bernardini, MD MSc FRCSC Princess Margaret Hospital - University Health Network
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01480999     History of Changes
Other Study ID Numbers: 11-0447-CE
Study First Received: October 19, 2011
Last Updated: November 24, 2011
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors

ClinicalTrials.gov processed this record on July 26, 2014