Trial record 8 of 920 for:    Uterine Diseases: Clinical Trials


This study is currently recruiting participants.
Verified May 2013 by CHA University
Information provided by (Responsible Party):
Taejong Song, CHA University Identifier:
First received: May 21, 2013
Last updated: May 22, 2013
Last verified: May 2013

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.

Condition Intervention Phase
Benign Uterine Disease
Procedure: LESS-TLH
Procedure: LESS-LAVH
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: a Randomized Comparison of Total Laparoscopic Hysterectomy (TLH) Versus Laparoscopically-assisted Vaginal Hysterectomy (LAVH)

Resource links provided by NLM:

Further study details as provided by CHA University:

Primary Outcome Measures:
  • Postoperative pain [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 76
Study Start Date: April 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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:

  • 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.
  Contacts and Locations
Please refer to this study by its identifier: NCT01861067

Contact: Taejong Song, M.D. +82-10-4035-8405

Korea, Republic of
CHA Gangnam Medical Center Recruiting
Seoul, Korea, Republic of, 135-081
Contact: Taejong Song, M.D.    +81-10-4035-8405   
Sponsors and Collaborators
CHA University
  More Information

No publications provided

Responsible Party: Taejong Song, Professor, CHA University Identifier: NCT01861067     History of Changes
Other Study ID Numbers: KNC13-014
Study First Received: May 21, 2013
Last Updated: May 22, 2013
Health Authority: Republic of Korea: Institutional Review Board

Additional relevant MeSH terms:
Uterine Diseases
Genital Diseases, Female processed this record on April 16, 2014