Completed

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

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What is being tested

single-port laparoscopic surgical staging

+ Four-port laparoscopic surgical staging

Procedure
Who is being recruted

Urogenital Diseases+9

+ Genital Diseases

+ Female Urogenital Diseases and Pregnancy Complications

Over 20 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2013
See protocol details

Summary

Principal SponsorAsan Medical Center
Last updated: November 30, 2022
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

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

NCT01679522
Principal SponsorAsan Medical Center
Last updated: November 30, 2022
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

107 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleNeoplasmsNeoplasms by SiteUrogenital NeoplasmsUterine DiseasesUterine NeoplasmsFemale Urogenital DiseasesEndometrial Neoplasms

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 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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Single-port laparoscopic surgical staging including total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection

Group II

Active Comparator
Four-port laparoscopic surgical staging including total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Seoul, South KoreaOpen Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center in Google Maps
CompletedOne Study Center