Endometrial CancerLESS-ENCT01679522
Feasibility Study of Laparoendoscopic Single Site Surgical Staging for Endometrial Cancer
A study testing single-port laparoscopic surgical staging and Four-port laparoscopic surgical staging in people with Endometrial Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
To compare the feasibility, safety, and efficacy between single-port and four-port laparoscopic surgical staging in patients with early stage endometrial cancer. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- single-port laparoscopic surgical staging and Four-port laparoscopic surgical staging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, 138-736
About this study
Official title: 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.
- Conditions
- Endometrial Cancer
- Being tested
- single-port laparoscopic surgical staging, Four-port laparoscopic surgical staging
- Keywords
- endometrial cancer, laparoscopic surgical staging, single-port, four-port
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single-port laparoscopic surgical stagingProcedure or surgery
single-port laparoscopic surgical staging indluding total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection
Four-port laparoscopic surgical stagingProcedure or surgery
Four-port laparoscopic surgical staging indluding total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| Single-port surgery group | Experimental | Single-port laparoscopic surgical staging including total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection Receives: Procedure: single-port laparoscopic surgical staging |
| Four-port surgery group | Active comparator | Four-port laparoscopic surgical staging including total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection Receives: Procedure: Four-port laparoscopic surgical staging |
What is being measured
The primary outcome is the main question the study is designed to answer.
operating time
Total operation time and time required for each procedure are calculated and compared.
Measured: 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.
Measured: 1 week after surgery
Secondary outcomes (6)
Postoperative pain
The VAS pain score was obtained every 8 hours after surgery and compared.
Measured: 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.
Measured: within 1 week after surgery
transfusion requirement and amount
Investigate and compare blood transfusion volume and frequency during and after surgery.
Measured: within 1 week after surgery
postoperative complications
Compare the frequency of fever, urinary retention, anemia, and nausea after surgery.
Measured: within 1 month after surgery
recurrence free survival
Compare RFS during the follow-up period.
Measured: 34 months after surgery
overall survival
Compare OS during the follow-up period.
Measured: 34 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startJan 2013
- Primary completionSep 2021
- Study completionJun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joo-Hyun Nam, Asan Medical Center
- Investigators
- Joo-Hyun Nam, M.D., Ph.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679522
- Sponsor's protocol ID
- LESS-E
- Acronym
- LESS-E
- Status last verified
- Nov 2022
- First submitted
- 3 Sep 2012
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kang OJ, Nam JH, Park JY. Laparo-endoscopic single-site versus conventional laparoscopic surgery for early-stage endometrial cancer: A randomized controlled non-inferiority trial. Gynecol Oncol. 2023 Jun;173:74-80. doi: 10.1016/j.ygyno.2023.04.005. Epub 2023 Apr 25.
PubMed 37105060
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparison of Single-port and Four-port Laparoscopic Staging Operation for Endometrial Cancer
- ClinicalTrials.gov ID
- NCT01679522
- Acronym / sponsor ID
- LESS-E / LESS-E
- Conditions
- Endometrial Cancer
- Keywords
- endometrial cancer, laparoscopic surgical staging, single-port, four-port
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Sep 2021 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 6 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the feasibility, safety, and efficacy between single-port and four-port laparoscopic surgical staging in patients with early stage endometrial cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-port surgery group | Experimental | Procedure: single-port laparoscopic surgical stagingSingle-port laparoscopic surgical staging including total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection |
| Four-port surgery group | Active comparator | Procedure: Four-port laparoscopic surgical stagingFour-port laparoscopic surgical staging including total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Previously untreated, histologically confirmed endometrial cancer
- Presumed FIGO stage 1
- Endometrioid adenocarcinoma
- patient who is planned to undergo surgical staging
- adequate oran function
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| single-port laparoscopic surgical stagingsingle-port laparoscopic surgical staging indluding total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection | Procedure or surgery | Single-port surgery group |
| Four-port laparoscopic surgical stagingFour-port laparoscopic surgical staging indluding total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection | Procedure or surgery | Four-port surgery group |
Primary outcome
operating time
Time frame: 1 day (Immediately after operation)
Total operation time and time required for each procedure are calculated and compared.
Number of lymph nodes retrieved
Time frame: 1 week after surgery
The number of right pelvic lymph nodes and left pelvic lymph nodes were obtained and compared.
6 secondary outcomes
Postoperative pain
Time frame: within 1 week after surgery
Postoperative analgesics requirement
Time frame: within 1 week after surgery
transfusion requirement and amount
Time frame: within 1 week after surgery
postoperative complications
Time frame: within 1 month after surgery
recurrence free survival
Time frame: 34 months after surgery
overall survival
Time frame: 34 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Derived from this study: PubMed 37105060Kang OJ, Nam JH, Park JY. Laparo-endoscopic single-site versus conventional laparoscopic surgery for early-stage endometrial cancer: A randomized controlled non-inferiority trial. Gynecol Oncol. 2023 Jun;173:74-80. doi: 10.1016/j.ygyno.2023.04.005. Epub 2023 Apr 25.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joo-Hyun Nam, M.D., Ph.D. principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single-port laparoscopic surgical staging and Four-port laparoscopic surgical staging in people with Endometrial Cancer, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operating time (time frame: 1 day (Immediately after operation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01679522, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.