Feasibility Study of Laparoendoscopic Single Site Surgical Staging for Endometrial Cancer
NCT ID: NCT01679522
Last Updated: 2022-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
107 participants
INTERVENTIONAL
2013-01-31
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Single-port surgery group
Single-port laparoscopic surgical staging including total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection
single-port laparoscopic surgical staging
single-port laparoscopic surgical staging indluding total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection
Four-port surgery group
Four-port laparoscopic surgical staging including total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection
Four-port laparoscopic surgical staging
Four-port laparoscopic surgical staging indluding total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection
Interventions
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single-port laparoscopic surgical staging
single-port laparoscopic surgical staging indluding total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection
Four-port laparoscopic surgical staging
Four-port laparoscopic surgical staging indluding total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
FEMALE
No
Sponsors
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Asan Medical Center
OTHER
Responsible Party
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Joo-Hyun Nam
Professor
Principal Investigators
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Joo-Hyun Nam, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, , South Korea
Countries
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References
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Kang OJ, Nam JH, Park JY. Laparo-endoscopic single-site versus conventional laparoscopic surgery for early-stage endometrial cancer: A randomized controlled non-inferiority trial. Gynecol Oncol. 2023 Jun;173:74-80. doi: 10.1016/j.ygyno.2023.04.005. Epub 2023 Apr 25.
Other Identifiers
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LESS-E
Identifier Type: -
Identifier Source: org_study_id
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