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2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-03-02 @ 6:23 PM
Study NCT ID:
NCT01861067
Status:
COMPLETED
Last Update Posted:
2015-04-16
First Post:
2013-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LESS-TLH Versus LESS-LAVH
Sponsor:
CHA University
Organization:
Study Overview
Official Title:
A Randomized Comparison of Laparoendoscopic Single-site (LESS) Hysterectomies: Total Laparoscopic Hysterectomy (TLH) Versus Laparoscopically Assisted Vaginal Hysterectomy (LAVH)
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: