Prospective Randomized Comparison of Single-port and Four-port Laparoscopic Staging Operation for Endometrial Cancer
N/A
20 Years
N/A
20 Years
N/A
Open (Enrolling)
Female
Endometrial Cancer
Female
Endometrial Cancer
Trial Information
Prospective Randomized Comparison of Single-port and Four-port Laparoscopic Staging Operation for Endometrial Cancer
Inclusion Criteria:
- Previously untreated, histologically confirmed endometrial cancer
- Presumed FIGO stage 1
- Endometrioid adenocarcinoma
- patient who is planned to undergo surgical staging
- adequate oran function
1. WBC > 3000 cells/mcl
2. Platelets > 100000/mcl
3. Creatinine < 2.0 mg/dL
4. Bilirubin < 1.5 * normal and SGOT or SGPT < 3 * normal
- American Society of Anesthesiologists Physical Status I-II
- Eastern Cooperative Oncology Group performance status 0-2
- Patients who have signed an approved Informed Consent
Exclusion Criteria:
- Uncontrolled medical disease
- Active infectious disease requiring antibiotics
- Previous pelvic radiation therapy
- Pregnant and lactating woman
- Patient who requires additional surgical procedures which are not necessary for
surgical staging of endometrial cancer
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
operating time
Outcome Time Frame:
1 day (Immediately after operation)
Safety Issue:
No
Principal Investigator
Joo-Hyun Nam, M.D., Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Asan Medical Center
Authority:
Korea: Asan Medical Center Institutional Review Borad
Study ID:
LESS-E
NCT ID:
NCT01679522
Start Date:
September 2012
Completion Date:
Related Keywords:
- Endometrial Cancer
- endometrial cancer
- laparoscopic surgical staging
- single-port
- four-port
- Endometrial Neoplasms
- Sarcoma, Endometrial Stromal
- Adenoma
Name | Location |
|---|
