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

Prospective Randomized Comparison of Single-port and Four-port Laparoscopic Staging Operation for Endometrial Cancer

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

Study Overview

• Status: Completed
• Conditions: Endometrial Cancer
• Intervention / Treatment: Procedure: single-port laparoscopic surgical staging; Procedure: Four-port laparoscopic surgical staging

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operating time	Total operation time and time required for each procedure are calculated and compared.	1 day (Immediately after operation)
Number of lymph nodes retrieved	The number of right pelvic lymph nodes and left pelvic lymph nodes were obtained and compared.	1 week after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	The VAS pain score was obtained every 8 hours after surgery and compared.	within 1 week after surgery
Postoperative analgesics requirement	If the VAS pain score is 3 or more or the patient desires, additional pain medication is administered. The frequency of the pain medication administered in this way is investigated and compared.	within 1 week after surgery
transfusion requirement and amount	Investigate and compare blood transfusion volume and frequency during and after surgery.	within 1 week after surgery
postoperative complications	Compare the frequency of fever, urinary retention, anemia, and nausea after surgery.	within 1 month after surgery
recurrence free survival	Compare RFS during the follow-up period.	34 months after surgery
overall survival	Compare OS during the follow-up period.	34 months after surgery

Collaborators and Investigators

• Sponsor: Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: September 3, 2012
• First Submitted That Met QC Criteria: September 5, 2012
• First Posted (Estimate): September 6, 2012

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: endometrial cancer; single-port; laparoscopic surgical staging; four-port
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endometrial Neoplasms
• Other Study ID Numbers: LESS-E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No