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Feasibility Study of Laparoendoscopic Single Site Surgical Staging for Endometrial Cancer (LESS-E)

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ClinicalTrials.gov Identifier: NCT01679522
Recruitment Status : Recruiting
First Posted : September 6, 2012
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Joo-Hyun Nam, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Procedure: single-port laparoscopic surgical staging Procedure: Four-port laparoscopic surgical staging Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Comparison of Single-port and Four-port Laparoscopic Staging Operation for Endometrial Cancer
Study Start Date : September 2012
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Arm Intervention/treatment
Experimental: 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
Procedure: 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

Active Comparator: 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
Procedure: 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




Primary Outcome Measures :
  1. operating time [ Time Frame: 1 day (Immediately after operation) ]
  2. Number of lymph nodes retrieved [ Time Frame: 1 week after surgery ]

Secondary Outcome Measures :
  1. Postoperative pain [ Time Frame: within 1 week after surgery ]
  2. Postoperative analgesics requirement [ Time Frame: within 1 week after surgery ]
  3. Quality of life [ Time Frame: within 6 months aftr surgery ]
  4. surgical stress response [ Time Frame: within 2 days after surgery ]
  5. transfusion requirement and amount [ Time Frame: within 1 week after surgery ]
  6. postoperative complication [ Time Frame: within 1 month after surgery ]
  7. time interval to return to work [ Time Frame: within 2 months after surgery ]
  8. recurrence free survival [ Time Frame: 2 year after surgery ]
  9. overall survival [ Time Frame: 2 years after surgery ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

    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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679522


Contacts
Contact: Joo-Hyun Nam, M.D., Ph.D. 82-10-3010-3633 jhnam@amc.seoul.kr

Locations
Korea, Republic of
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Joo-Hyun Nam, M.D., Ph.D.    82-2-3010-3633    jhnam@amc.seoul.kr   
Sub-Investigator: Jong-Hyeok Kim, M.D., Ph.D.         
Sub-Investigator: Dae-Yeon Kim, M.D., Ph.D.         
Sub-Investigator: Jeong-Yeol Park, M.D., Ph.D.         
Principal Investigator: Joo-Hyun Nam, M.D., Ph.D.         
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Joo-Hyun Nam, M.D., Ph.D. Asan Medical Center

Responsible Party: Joo-Hyun Nam, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01679522     History of Changes
Other Study ID Numbers: LESS-E
First Posted: September 6, 2012    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017

Keywords provided by Joo-Hyun Nam, Asan Medical Center:
endometrial cancer
laparoscopic surgical staging
single-port
four-port

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female