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

NCT ID: NCT01480999

Last Updated: 2020-08-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 550 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2020-08-31

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.

Conditions

Cancer of the Endometrium

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Laparotomy (open surgery)

No interventions assigned to this group

Laparoscopic surgery

No interventions assigned to this group

Robotic assisted surgery

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcus Q Bernardini, MD MSc FRCSC

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, University Health Network

Locations

Cross Cancer Institute

Edmonton, Alberta, Canada

Kingston General Hospital

Kingston, Ontario, Canada

Sunnybrook Regional Cancer Centre

Toronto, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Hopital Notre-Dame du CHUM

Montreal, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Countries

Canada

Other Identifiers

11-0447-CE

Identifier Type: -

Identifier Source: org_study_id