Clinical trial NCT01480999: Comparing Robotics and Laparoscopy With Laparotomy/Open Surgery for Endometrial Cancer
Official title: A Prospective Study Evaluating Surgical and Quality of Life Outcomes in Robotics and Laparoscopy Compared to Laparotomy in Early Stage Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer of the Endometrium
Keywords: Laparotomy
Open Surgery
Laparoscopy
Robotic surgery
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2011-11-29
Enrollment: 550
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Surgical Outcomes
timeFrame: 6 months
measure: Quality of Life Outcomes
timeFrame: 6 months
measure: Cost-effectiveness
timeFrame: 6 months
Secondary outcomes:
measure: Evolution of MIS rates
timeFrame: Prior to recruitment of the first patient and every 6 months for the duration of the study
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hopital Notre-Dame du CHUM
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
state: Saskatchewan
Study officials:
affiliation: Princess Margaret Hospital, University Health Network
name: Marcus Q Bernardini, MD MSc FRCSC
role: PRINCIPAL_INVESTIGATOR
References: