Comparing Robotics and Laparoscopy With Laparotomy/Open Surgery for Endometrial Cancer (GOC2)
This study is not yet open for participant recruitment.
Verified November 2011 by University Health Network, Toronto
Sponsor:
University Health Network, Toronto
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
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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
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 Adenoma 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 Neoplasms, Glandular and Epithelial |
ClinicalTrials.gov processed this record on May 16, 2013