LESS-TLH Versus LESS-LAVH
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|ClinicalTrials.gov Identifier: NCT01861067|
Recruitment Status : Completed
First Posted : May 23, 2013
Last Update Posted : April 16, 2015
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
laparoendoscopic single-site (LESS) total laparoscopic hysterectomy (TLH)
Active Comparator: LESS-LAVH
laparoendoscopic single-site (LESS) laparoscopically-assisted vaginal hysterectomy (LAVH)
- Operative time [ Time Frame: Surgery date ]Operative time was defined as the time from skin incision to skin closure, which was electronically recorded.
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
|Korea, Republic of|
|CHA Gangnam Medical Center|
|Seoul, Korea, Republic of, 135-081|
|Principal Investigator:||Taejong Song, MD PhD||CHA Gangnam Medical center|