Clinical trial NCT01861067: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Benign Uterine Disease
Lead sponsor: CHA University
Sponsor class: OTHER
First posted: 2013-05-23
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Operative time
timeFrame: Surgery date
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: CHA Gangnam Medical Center
Study officials:
affiliation: CHA Gangnam Medical center
name: Taejong Song, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.