Know Cancer

or
forgot password

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


N/A
18 Years
N/A
Not Enrolling
Female
Cancer of the Endometrium

Thank you

Trial Information

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


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 ┬Ámmol/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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Surgical Outcomes

Outcome Description:

Intraoperative complications as well as perioperative (time to discharge from hospital), early postoperative (<4 weeks) and long-term morbidity (4 weeks to 6 months)

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Marcus Q Bernardini, MD MSc FRCSC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital - University Health Network

Authority:

Canada: Ethics Review Committee

Study ID:

11-0447-CE

NCT ID:

NCT01480999

Start Date:

December 2011

Completion Date:

May 2014

Related Keywords:

  • Cancer of the Endometrium
  • Laparotomy
  • Open Surgery
  • Laparoscopy
  • Robotic surgery
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021
Duke Durham, North Carolina  27710