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Clinical Trials/NCT01679522
NCT01679522CompletedNot Applicable

Prospective Randomized Comparison of Single-port and Four-port Laparoscopic Staging Operation for Endometrial Cancer

Asan Medical Center2 sites in 1 country107 target enrollmentStarted: January 2013Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
107
Locations
2
Primary Endpoint
operating time
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To compare the feasibility, safety, and efficacy between single-port and four-port laparoscopic surgical staging in patients with early stage endometrial cancer.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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
  • •WBC > 3000 cells/mcl
  • •Platelets > 100000/mcl
  • •Creatinine < 2.0 mg/dL
  • •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

Outcomes

Primary Outcomes

operating time

Time Frame: 1 day (Immediately after operation)

Total operation time and time required for each procedure are calculated and compared.

Number of lymph nodes retrieved

Time Frame: 1 week after surgery

The number of right pelvic lymph nodes and left pelvic lymph nodes were obtained and compared.

Secondary Outcomes

  • transfusion requirement and amount(within 1 week after surgery)
  • Postoperative pain(within 1 week after surgery)
  • Postoperative analgesics requirement(within 1 week after surgery)
  • postoperative complications(within 1 month after surgery)
  • recurrence free survival(34 months after surgery)
  • overall survival(34 months after surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Joo-Hyun Nam

Professor

Asan Medical Center

Study Sites (2)

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