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

This study is currently recruiting participants.
Verified September 2012 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Joo-Hyun Nam, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01679522
First received: September 3, 2012
Last updated: September 8, 2012
Last verified: September 2012
History of Changes
  Purpose

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


Condition Intervention
Endometrial Cancer
 Procedure: single-port laparoscopic surgical staging
Procedure: Four-port laparoscopic surgical staging

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Comparison of Single-port and Four-port Laparoscopic Staging Operation for Endometrial Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • operating time [ Time Frame: 1 day (Immediately after operation) ] [ Designated as safety issue: No ]
  • Number of lymph nodes retrieved [ Time Frame: 1 week after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative pain [ Time Frame: within 1 week after surgery ] [ Designated as safety issue: No ]
  • Postoperative analgesics requirement [ Time Frame: within 1 week after surgery ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: within 6 months aftr surgery ] [ Designated as safety issue: No ]
  • surgical stress response [ Time Frame: within 2 days after surgery ] [ Designated as safety issue: No ]
  • transfusion requirement and amount [ Time Frame: within 1 week after surgery ] [ Designated as safety issue: Yes ]
  • postoperative complication [ Time Frame: within 1 month after surgery ] [ Designated as safety issue: Yes ]
  • time interval to return to work [ Time Frame: within 2 months after surgery ] [ Designated as safety issue: No ]
  • recurrence free survival [ Time Frame: 2 year after surgery ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 2 years after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 108
Study Start Date: September 2012
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Joo-Hyun Nam, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01679522     History of Changes
Other Study ID Numbers: LESS-E
Study First Received: September 3, 2012
Last Updated: September 8, 2012
Health Authority: Korea: Asan Medical Center Institutional Review Borad

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

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Adenoma
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 23, 2013