A Phase 3 interventional study of LESS-TLH and LESS-LAVH in Benign Uterine Disease, sponsored by CHA University. Completed at 1 site in Korea, Republic of. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-04-16.
Sponsored by CHA University · Phase 3, Interventional, and Treatment
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.
66 studies on the registry are indexed under Uterine Diseases; 8 are open to participants now.
This study's enrollment of 76 is below the median of 98 across 52 interventional studies indexed under Uterine Diseases.
Browse Uterine Diseases studies →CHA University is the lead sponsor of 54 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
laparoendoscopic single-site (LESS) total laparoscopic hysterectomy (TLH)
Procedure: LESS-TLH
laparoendoscopic single-site (LESS) laparoscopically-assisted vaginal hysterectomy (LAVH)
Procedure: LESS-LAVH
Operative time
Operative time was defined as the time from skin incision to skin closure, which was electronically recorded.
Time frame: Surgery date
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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CHA University