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

Cancer of the Endometrium Clinical Trial

— GOC2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480999
• Other study ID #: 11-0447-CE
• Status: Completed
• Start date: November 2011
• Est. completion date: August 2020

Study information

• Verified date: August 2020
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: August 2020
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of the Endometrium
• Endometrial Neoplasms

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Kingston General Hospital	Kingston	Ontario
Canada	Hopital Notre-Dame du CHUM	Montreal	Quebec
Canada	Jewish General Hospital	Montreal	Quebec
Canada	Saskatoon Cancer Centre	Saskatoon	Saskatchewan
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Sunnybrook Regional Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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