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Clinical Trials/NCT01679522
NCT01679522
Completed
Not Applicable

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

Asan Medical Center1 site in 1 country107 target enrollmentJanuary 2013
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ConditionsEndometrial Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endometrial Cancer
Sponsor
Asan Medical Center
Enrollment
107
Locations
1
Primary Endpoint
operating time
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
June 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joo-Hyun Nam

Professor

Asan Medical Center

Eligibility Criteria

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

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)

Study Sites (1)

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