LESS-TLH Versus LESS-LAVH

CHA University

Status and phase: Completed; Phase 3

Conditions: Benign Uterine Disease

Treatments: Procedure: LESS-LAVH; Procedure: LESS-TLH

Study type: Interventional

Funder types: Other

Identifiers

NCT01861067

KNC13-014

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

76 participants in 2 patient groups

LESS-TLH

Experimental group

Description:

laparoendoscopic single-site (LESS) total laparoscopic hysterectomy (TLH)

Treatment:

Procedure: LESS-TLH

LESS-LAVH

Active Comparator group

Description:

laparoendoscopic single-site (LESS) laparoscopically-assisted vaginal hysterectomy (LAVH)

Treatment:

Procedure: LESS-LAVH