Benign or Preinvasive Uterine DiseaseNCT01679548
Study of Laparoendoscopic Single Site Hysterectomy in Benign and Preinvasive Uterine Disease
A study testing Single-port LAVH and Three-port LAVH in people with Benign or Preinvasive Uterine Disease, run by Asan Medical Center at 1 site in South Korea.
Trial summary
To compare the efficacy between single-port and three-port laparoscopic assisted vaginal hysterectomy in patients with benign or preinvasive uterine disease Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Benign or Preinvasive Uterine Disease
- What is being tested?
- Single-port LAVH and Three-port LAVH
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Nov 2012to 11 Jun 2019
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who undergo laparoscopic assisted vaginal hysterectomy due to following gynecologic disease
- uterine leiomyoma
- uterine adenomyosis
- Endometrial hyperplasia
- cervical intraepithelial neoplasia including carcinoma in situ
- Dysfunctional uterine bleeding
Show all 9Show fewer
- Other benign gynecologic disease requiring hysterectomy
- American Society of Anesthesiologists Physical Status classification I-II
- Patient who have signed an written informed consent
Who cannot join
- Uncontrolled medical disease
- Active infectious disease
- Previous pelvic radiation therapy
- Patient who requiring further procedure excluding hysterectomy, unilateral or bilateral salpingooophorectomy / salpingectomy / oophorectomy
- Patient who undergoes subtotal hysterectomy
- Patient who have other pain source excluding gynecologic disease
- Pregnancy and lactating woman
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 Three-port Laparoscopic Assisted Vaginal Hysterectomy
To compare the efficacy between single-port and three-port laparoscopic assisted vaginal hysterectomy in patients with benign or preinvasive uterine disease
Read the detailed description
This study intended to conduct a randomized trial to determine whether LESS LAVH has a faster recovery rate than three-port LAVH.
- Conditions
- Benign or Preinvasive Uterine Disease
- Being tested
- Single-port LAVH, Three-port LAVH
- Keywords
- LESS, Benign uterine disease, LAVH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-port LAVHProcedure or surgery
LESS LAVH was performed using a commercially available four-channel, single-port system. A rigid, 0-degree, 5 mm laparoscope was used.
Three-port LAVHProcedure or surgery
Conventional LAVH was performed using three ports; a 12, 10, and 5-mm port was placed in the umbilicus, left lower quadrant, and suprapubic area, respectively. A rigid, 0-degree, 12 mm laparoscope was introduced through 12mm port of umbilicus.
| Study group | Role | What they receive |
|---|---|---|
| Single-port LAVH group | Experimental | single-port laparoscopic assisted vaginal hysterectomy Receives: Procedure: Single-port LAVH |
| Three-port LAVH group | Active comparator | three-port laparoscopic assisted vaginal hysterectomy Receives: Procedure: Three-port LAVH |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative hospital stay
The primary endpoint was to compare average length of postoperative hospital stay and the ratio of patients discharged within 2 days after surgery between LESS and conventional groups.
Measured: within 1 week after surgery
Secondary outcomes (5)
postoperative pain
Postoperative pain was recorded using the Visual Analog Pain Scale (VAS), scored from 1 to 10 (0 is no pain and 10 is agonizing pain)
Measured: within 1 week after surgery
postoperative analgesics requirement
Whenever patients requested additional analgesia, they were administered parenterally.
Measured: within 1 week after surgery
operating time
skin to skin operation time was recorded
Measured: 1 day (immediately ater surgery)
Transfusion requirement and amount
Transfusion requirement and amount were recorede
Measured: within 1 week after surgery
intra and postoperative complication
intra and post operative complications were recorede
Measured: within 1 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 start23 Nov 2012
- Primary completion12 Dec 2018
- Study completion11 Jun 2019
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 Benign or Preinvasive Uterine DiseaseStudies 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
- 424 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
- NCT01679548
- Sponsor's protocol ID
- LESS-H
- Status last verified
- Mar 2024
- First submitted
- 3 Sep 2012
- Last updated
- 25 Mar 2024
- 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. Comparison of single-site and three-port hysterectomy for benign uterine diseases: A randomised trial (LESS-H). Eur J Obstet Gynecol Reprod Biol. 2025 Apr 17;308:251-256. doi: 10.1016/j.ejogrb.2025.03.005. Epub 2025 Mar 10.
PubMed 40088545
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparison of Single-port and Three-port Laparoscopic Assisted Vaginal Hysterectomy
- ClinicalTrials.gov ID
- NCT01679548
- Acronym / sponsor ID
- LESS-H
- Conditions
- Benign or Preinvasive Uterine Disease
- Keywords
- LESS, Benign uterine disease, LAVH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 23 Nov 2012 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 11 Jun 2019 (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 efficacy between single-port and three-port laparoscopic assisted vaginal hysterectomy in patients with benign or preinvasive uterine disease
Detailed description
This study intended to conduct a randomized trial to determine whether LESS LAVH has a faster recovery rate than three-port LAVH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-port LAVH group | Experimental | Procedure: Single-port LAVHsingle-port laparoscopic assisted vaginal hysterectomy |
| Three-port LAVH group | Active comparator | Procedure: Three-port LAVHthree-port laparoscopic assisted vaginal hysterectomy |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient who undergo laparoscopic assisted vaginal hysterectomy due to following gynecologic disease
- American Society of Anesthesiologists Physical Status classification I-II
- Patient who have signed an written informed consent
Key exclusion criteria (7 listed)
- Uncontrolled medical disease
- Active infectious disease
- Previous pelvic radiation therapy
- Patient who requiring further procedure excluding hysterectomy, unilateral or bilateral salpingooophorectomy / salpingectomy / oophorectomy
- Patient who undergoes subtotal hysterectomy
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 LAVHLESS LAVH was performed using a commercially available four-channel, single-port system. A rigid, 0-degree, 5 mm laparoscope was used. | Procedure or surgery | Single-port LAVH group |
| Three-port LAVHConventional LAVH was performed using three ports; a 12, 10, and 5-mm port was placed in the umbilicus, left lower quadrant, and suprapubic area, respectively. A rigid, 0-degree, 12 mm laparoscope was introduced through 12mm port of umbilicus. | Procedure or surgery | Three-port LAVH group |
Primary outcome
postoperative hospital stay
Time frame: within 1 week after surgery
The primary endpoint was to compare average length of postoperative hospital stay and the ratio of patients discharged within 2 days after surgery between LESS and conventional groups.
5 secondary outcomes
postoperative pain
Time frame: within 1 week after surgery
postoperative analgesics requirement
Time frame: within 1 week after surgery
operating time
Time frame: 1 day (immediately ater surgery)
Transfusion requirement and amount
Time frame: within 1 week after surgery
intra and postoperative complication
Time frame: within 1 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 25 Mar 2024.
- Derived from this study: PubMed 40088545Kang OJ, Nam JH, Park JY. Comparison of single-site and three-port hysterectomy for benign uterine diseases: A randomised trial (LESS-H). Eur J Obstet Gynecol Reprod Biol. 2025 Apr 17;308:251-256. doi: 10.1016/j.ejogrb.2025.03.005. Epub 2025 Mar 10.
- Individual participant dataSharing planned: Undecided
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 LAVH and Three-port LAVH in people with Benign or Preinvasive Uterine Disease, 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 9 inclusion and 7 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 25 Mar 2024. 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?
postoperative hospital stay (time frame: within 1 week after surgery). 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 NCT01679548, 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 25 Mar 2024.