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

NCT01480999 | Completed DMC

• 1 other identifier: 11-0447-CE
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 7

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

Keywords

Laparotomy; Open Surgery; Laparoscopy; Robotic surgery

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Evolution of MIS rates

  Prior to recruitment of the first patient and every 6 months for the duration of the study

Study Arms (3)

Laparotomy (open surgery)

Laparoscopic surgery

Robotic assisted surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (7)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L5P9, Canada

Location

Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Hopital Notre-Dame du CHUM

Montreal, Quebec, H2L 4M1, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Marcus Q Bernardini, MD MSc FRCSC

  Princess Margaret Hospital, University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2011
• First Posted: November 29, 2011
• Study Start: November 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2020
• Last Updated: August 28, 2020

Record last verified: 2020-08

Locations

CA (7)