LESS-TLH Versus LESS-LAVH

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by CHA University
Sponsor:
Information provided by (Responsible Party):
Taejong Song, CHA University
ClinicalTrials.gov Identifier:
NCT01861067
First received: May 21, 2013
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Laparoendoscopic Single-site (LESS) Hysterectomies: 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:
  • Operative time [ Time Frame: Surgery date ] [ Designated as safety issue: No ]
    Operative time was defined as the time from skin incision to skin closure, which was electronically recorded.


Estimated Enrollment: 76
Study Start Date: April 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (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

  Eligibility

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

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:

  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01861067

Contacts
Contact: Taejong Song, M.D. +82-10-4035-8405 taejong.song@gmail.com

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

No publications provided

Responsible Party: Taejong Song, Professor, CHA University
ClinicalTrials.gov Identifier: NCT01861067     History of Changes
Other Study ID Numbers: KNC13-014
Study First Received: May 21, 2013
Last Updated: May 8, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 20, 2014