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  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01480999
First received: October 19, 2011
Last updated: December 1, 2014
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.


Enrollment: 550
Study Start Date: November 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (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
  • 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

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L5P9
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
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
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: December 1, 2014
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
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on April 19, 2015