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CompletedNCT01861067Updated Apr 16, 2015

LESS-TLH Versus LESS-LAVH

A Phase 3 interventional study of LESS-TLH and LESS-LAVH in Benign Uterine Disease, sponsored by CHA University. Completed at 1 site in Korea, Republic of. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-04-16.

Sponsored by CHA University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
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Study summary

During the last 2 decades, several studies have tried to define the best surgical approach to hysterectomy for benign uterine diseases1. Accumulating evidence demonstrates that abdominal hysterectomy has a higher incidence of complications, a longer hospital stay and a slower convalescence in comparison with laparoscopic hysterectomy (LH). The main advantage of LHs is the absence of a wide abdominal scar, which results in fewer wound-related complications and in a significant decrease of postoperative pain.

Technologic advances in endoscopic instrumentation and optics have allowed the development of an even less invasive procedure than conventional LH using multiple ports: laparoendoscopic single-site (LESS) surgery, also known as single-port access (SPA) laparoscopy3. In the LESS approaches, total laparoscopic hysterectomy (TLH) and laparoscopically-assisted vaginal hysterectomy (LAVH) are all feasible, with comparable conventional LH. However, it is yet to be determined which of two alternative and less invasive approaches (LESS-TLH and LESS-LAVH) should be preferred. In particular, none has focused on postoperative pain as the primary outcome of the study. The investigators have therefore designed the randomized trial to investigate specifically differences in postoperative pain after LESS-TLH and LESS-LAVH.

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Conditions studied

  • Benign Uterine Disease

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03

In context

Uterine Diseases

66 studies on the registry are indexed under Uterine Diseases; 8 are open to participants now.

This study's enrollment of 76 is below the median of 98 across 52 interventional studies indexed under Uterine Diseases.

Browse Uterine Diseases studies →

Lead sponsor

CHA University is the lead sponsor of 54 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • women with indication for hysterectomy for a supposed benign uterine disease
  • women with an age of 18 years or older
  • women who were not pregnant at the time of presentation
  • women who were appropriated medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2)

Exclusion criteria

Exclusion Criteria:

  • uterine volume > 18 weeks of gestation by pelvic examination
  • suspicion of malignancy
  • pelvic organ prolapse > stage 1 according to POP-Q classification
  • inability to understand and provide written informed consent.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
76 participants (actual)

Study arms

  • Experimental
    LESS-TLH

    laparoendoscopic single-site (LESS) total laparoscopic hysterectomy (TLH)

    Procedure: LESS-TLH

  • Active comparator
    LESS-LAVH

    laparoendoscopic single-site (LESS) laparoscopically-assisted vaginal hysterectomy (LAVH)

    Procedure: LESS-LAVH

Interventions

  • ProcedureLESS-TLH
  • ProcedureLESS-LAVH
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What researchers measure

Primary outcomes

  1. Operative time

    Operative time was defined as the time from skin incision to skin closure, which was electronically recorded.

    Time frame: Surgery date

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Study locations

1 site
  • CHA Gangnam Medical Center
    Seoul, 135-081, Korea, Republic of
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References and documents

Publications

  • Song T, Kim MK, Kim ML, Jung YW, Yun BS, Seong SJ. A Randomized Comparison of Laparoendoscopic Single-Site Hysterectomies: Total Laparoscopic Hysterectomy Versus Laparoscopically Assisted Vaginal Hysterectomy. J Laparoendosc Adv Surg Tech A. 2015 Jul;25(7):541-7. doi: 10.1089/lap.2014.0524. Epub 2015 Jun 15. PubMed 26075931 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01861067
Lead sponsor
CHA University
Responsible party
Taejong Song (Professor, CHA University) — Principal investigator
First posted
May 23, 2013
Start date
Apr 2013
Primary completion
Jan 2014
Completion
Jan 2014
Last update
Apr 16, 2015

Study contacts

Taejong Song, MD PhD
principal investigator · CHA Gangnam Medical center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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