Study of Laparoendoscopic Single Site Hysterectomy in Benign and Preinvasive Uterine Disease

NCT01679548 | Completed

• 1 other identifier: LESS-H
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the efficacy between single-port and three-port laparoscopic assisted vaginal hysterectomy in patients with benign or preinvasive uterine disease

Conditions

Benign or Preinvasive Uterine Disease

Keywords

LESS; Benign uterine disease; LAVH

Outcome Measures

Primary Outcomes (1)

• postoperative hospital stay

  The primary endpoint was to compare average length of postoperative hospital stay and the ratio of patients discharged within 2 days after surgery between LESS and conventional groups.

  within 1 week after surgery

Secondary Outcomes (5)

• postoperative pain

  within 1 week after surgery

• postoperative analgesics requirement

  within 1 week after surgery

• operating time

  1 day (immediately ater surgery)

• Transfusion requirement and amount

  within 1 week after surgery

• intra and postoperative complication

  within 1 months after surgery

Study Arms (2)

Single-port LAVH group

EXPERIMENTAL

single-port laparoscopic assisted vaginal hysterectomy

Procedure: Single-port LAVH

Three-port LAVH group

ACTIVE COMPARATOR

three-port laparoscopic assisted vaginal hysterectomy

Procedure: Three-port LAVH

Interventions

Single-port LAVH PROCEDURE

LESS LAVH was performed using a commercially available four-channel, single-port system. A rigid, 0-degree, 5 mm laparoscope was used.

Single-port LAVH group

Three-port LAVH PROCEDURE

Conventional LAVH was performed using three ports; a 12, 10, and 5-mm port was placed in the umbilicus, left lower quadrant, and suprapubic area, respectively. A rigid, 0-degree, 12 mm laparoscope was introduced through 12mm port of umbilicus.

Three-port LAVH group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient who undergo laparoscopic assisted vaginal hysterectomy due to following gynecologic disease
• uterine leiomyoma
• uterine adenomyosis
• Endometrial hyperplasia
• cervical intraepithelial neoplasia including carcinoma in situ
• Dysfunctional uterine bleeding
• Other benign gynecologic disease requiring hysterectomy
• American Society of Anesthesiologists Physical Status classification I-II
• Patient who have signed an written informed consent

You may not qualify if:

• Uncontrolled medical disease
• Active infectious disease
• Previous pelvic radiation therapy
• Patient who requiring further procedure excluding hysterectomy, unilateral or bilateral salpingooophorectomy / salpingectomy / oophorectomy
• Patient who undergoes subtotal hysterectomy
• Patient who have other pain source excluding gynecologic disease
• Pregnancy and lactating woman

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (1)

• Kang OJ, Nam JH, Park JY. Comparison of single-site and three-port hysterectomy for benign uterine diseases: A randomised trial (LESS-H). Eur J Obstet Gynecol Reprod Biol. 2025 Apr 17;308:251-256. doi: 10.1016/j.ejogrb.2025.03.005. Epub 2025 Mar 10.

  PMID: 40088545 DERIVED

Study Officials

• Joo-Hyun Nam, M.D., Ph.D.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 3, 2012
• First Posted: September 6, 2012
• Study Start: November 23, 2012
• Primary Completion: December 12, 2018
• Study Completion: June 11, 2019
• Last Updated: March 25, 2024

Record last verified: 2024-03

Locations

KR (1)