LESS-TLH Versus LESS-LAVH
Primary Purpose
Benign Uterine Disease
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
LESS-TLH
LESS-LAVH
Sponsored by
About this trial
This is an interventional treatment trial for Benign Uterine Disease
Eligibility 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.
Sites / Locations
- CHA Gangnam Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LESS-TLH
LESS-LAVH
Arm Description
laparoendoscopic single-site (LESS) total laparoscopic hysterectomy (TLH)
laparoendoscopic single-site (LESS) laparoscopically-assisted vaginal hysterectomy (LAVH)
Outcomes
Primary Outcome Measures
Operative time
Operative time was defined as the time from skin incision to skin closure, which was electronically recorded.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01861067
Brief Title
LESS-TLH Versus LESS-LAVH
Official Title
A Randomized Comparison of Laparoendoscopic Single-site (LESS) Hysterectomies: Total Laparoscopic Hysterectomy (TLH) Versus Laparoscopically Assisted Vaginal Hysterectomy (LAVH)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHA University
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Uterine Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LESS-TLH
Arm Type
Experimental
Arm Description
laparoendoscopic single-site (LESS) total laparoscopic hysterectomy (TLH)
Arm Title
LESS-LAVH
Arm Type
Active Comparator
Arm Description
laparoendoscopic single-site (LESS) laparoscopically-assisted vaginal hysterectomy (LAVH)
Intervention Type
Procedure
Intervention Name(s)
LESS-TLH
Intervention Type
Procedure
Intervention Name(s)
LESS-LAVH
Primary Outcome Measure Information:
Title
Operative time
Description
Operative time was defined as the time from skin incision to skin closure, which was electronically recorded.
Time Frame
Surgery date
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taejong Song, MD PhD
Organizational Affiliation
CHA Gangnam Medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHA Gangnam Medical Center
City
Seoul
ZIP/Postal Code
135-081
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
26075931
Citation
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.
Results Reference
derived
Learn more about this trial
LESS-TLH Versus LESS-LAVH
We'll reach out to this number within 24 hrs