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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Asan Medical Center.
Recruitment status was:  Recruiting
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
  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
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:


Further study details as provided by Asan Medical Center:

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

Secondary Outcome Measures:
  • 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 ]

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   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679522

Locations
Korea, Republic of
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Joo-Hyun Nam, M.D., Ph.D. Asan Medical Center
  More Information

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

Keywords provided by 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

ClinicalTrials.gov processed this record on January 19, 2017