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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01679522
Recruitment Status : Unknown
Verified May 2017 by Joo-Hyun Nam, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : September 6, 2012
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Joo-Hyun Nam, Asan Medical Center

Tracking Information
First Submitted Date  ICMJE September 3, 2012
First Posted Date  ICMJE September 6, 2012
Last Update Posted Date May 31, 2017
Study Start Date  ICMJE September 2012
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2012)
  • operating time [ Time Frame: 1 day (Immediately after operation) ]
  • Number of lymph nodes retrieved [ Time Frame: 1 week after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2012)
  • Postoperative pain [ Time Frame: within 1 week after surgery ]
  • Postoperative analgesics requirement [ Time Frame: within 1 week after surgery ]
  • Quality of life [ Time Frame: within 6 months aftr surgery ]
  • surgical stress response [ Time Frame: within 2 days after surgery ]
  • transfusion requirement and amount [ Time Frame: within 1 week after surgery ]
  • postoperative complication [ Time Frame: within 1 month after surgery ]
  • time interval to return to work [ Time Frame: within 2 months after surgery ]
  • recurrence free survival [ Time Frame: 2 year after surgery ]
  • overall survival [ Time Frame: 2 years after surgery ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2012)
  • Postoperative pain [ Time Frame: within 1 week after surgery ]
  • Postoperative analgesics requirement [ Time Frame: within 1 week after surgery ]
  • Quality of life [ Time Frame: within 6 months aftr surgery ]
  • surgical stress response [ Time Frame: within 2 days after surgery ]
  • trasfusion requirement and amount [ Time Frame: within 1 week after surgery ]
  • postoperative complication [ Time Frame: within 1 month after surgery ]
  • time interval to return to work [ Time Frame: within 2 months after surgery ]
  • recurrence free survival [ Time Frame: 2 year after surgery ]
  • overall survival [ Time Frame: 2 years after surgery ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility Study of Laparoendoscopic Single Site Surgical Staging for Endometrial Cancer
Official Title  ICMJE Prospective Randomized Comparison of Single-port and Four-port Laparoscopic Staging Operation for Endometrial Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Endometrial Cancer
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Procedure: single-port laparoscopic surgical staging
  • 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
    Intervention: Procedure: Four-port laparoscopic surgical staging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 5, 2012)
108
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2018
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01679522
Other Study ID Numbers  ICMJE LESS-E
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joo-Hyun Nam, Asan Medical Center
Study Sponsor  ICMJE Asan Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joo-Hyun Nam, M.D., Ph.D. Asan Medical Center
PRS Account Asan Medical Center
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP