We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

LESS-TLH Versus LESS-LAVH

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01861067
Recruitment Status : Completed
First Posted : May 23, 2013
Last Update Posted : April 16, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Benign Uterine Disease Procedure: LESS-TLH Procedure: LESS-LAVH Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Study Start Date : April 2013
Primary Completion Date : January 2014
Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Operative time [ Time Frame: Surgery date ]
    Operative time was defined as the time from skin incision to skin closure, which was electronically recorded.


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861067


Locations
Korea, Republic of
CHA Gangnam Medical Center
Seoul, Korea, Republic of, 135-081
Sponsors and Collaborators
CHA University
Investigators
Principal Investigator: Taejong Song, MD PhD CHA Gangnam Medical center
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Taejong Song, Professor, CHA University
ClinicalTrials.gov Identifier: NCT01861067     History of Changes
Other Study ID Numbers: KNC13-014
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Uterine Diseases
Genital Diseases, Female