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

Primary Purpose

Endometrial Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
single-port laparoscopic surgical staging
Four-port laparoscopic surgical staging
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring endometrial cancer, laparoscopic surgical staging, single-port, four-port

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Single-port surgery group

Four-port surgery group

Arm Description

Single-port laparoscopic surgical staging including total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection

Four-port laparoscopic surgical staging including total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection

Outcomes

Primary Outcome Measures

operating time
Total operation time and time required for each procedure are calculated and compared.
Number of lymph nodes retrieved
The number of right pelvic lymph nodes and left pelvic lymph nodes were obtained and compared.

Secondary Outcome Measures

Postoperative pain
The VAS pain score was obtained every 8 hours after surgery and compared.
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.
transfusion requirement and amount
Investigate and compare blood transfusion volume and frequency during and after surgery.
postoperative complications
Compare the frequency of fever, urinary retention, anemia, and nausea after surgery.
recurrence free survival
Compare RFS during the follow-up period.
overall survival
Compare OS during the follow-up period.

Full Information

First Posted
September 3, 2012
Last Updated
November 28, 2022
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01679522
Brief Title
Feasibility Study of Laparoendoscopic Single Site Surgical Staging for Endometrial Cancer
Acronym
LESS-E
Official Title
Prospective Randomized Comparison of Single-port and Four-port Laparoscopic Staging Operation for Endometrial Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
September 2021 (Actual)
Study Completion Date
June 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
endometrial cancer, laparoscopic surgical staging, single-port, four-port

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single-port surgery group
Arm Type
Experimental
Arm Description
Single-port laparoscopic surgical staging including total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection
Arm Title
Four-port surgery group
Arm Type
Active Comparator
Arm Description
Four-port laparoscopic surgical staging including total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection
Intervention Type
Procedure
Intervention Name(s)
single-port laparoscopic surgical staging
Intervention Description
single-port laparoscopic surgical staging indluding total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection
Intervention Type
Procedure
Intervention Name(s)
Four-port laparoscopic surgical staging
Intervention Description
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 Measure Information:
Title
operating time
Description
Total operation time and time required for each procedure are calculated and compared.
Time Frame
1 day (Immediately after operation)
Title
Number of lymph nodes retrieved
Description
The number of right pelvic lymph nodes and left pelvic lymph nodes were obtained and compared.
Time Frame
1 week after surgery
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
The VAS pain score was obtained every 8 hours after surgery and compared.
Time Frame
within 1 week after surgery
Title
Postoperative analgesics requirement
Description
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.
Time Frame
within 1 week after surgery
Title
transfusion requirement and amount
Description
Investigate and compare blood transfusion volume and frequency during and after surgery.
Time Frame
within 1 week after surgery
Title
postoperative complications
Description
Compare the frequency of fever, urinary retention, anemia, and nausea after surgery.
Time Frame
within 1 month after surgery
Title
recurrence free survival
Description
Compare RFS during the follow-up period.
Time Frame
34 months after surgery
Title
overall survival
Description
Compare OS during the follow-up period.
Time Frame
34 months after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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 WBC > 3000 cells/mcl Platelets > 100000/mcl Creatinine < 2.0 mg/dL 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joo-Hyun Nam, M.D., Ph.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Feasibility Study of Laparoendoscopic Single Site Surgical Staging for Endometrial Cancer

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