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

Prospective Randomized Comparison of Single-port and Three-port Laparoscopic Assisted Vaginal Hysterectomy

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

Study Overview

• Status: Completed
• Conditions: Benign or Preinvasive Uterine Disease
• Intervention / Treatment: Procedure: Single-port LAVH; Procedure: Three-port LAVH

Detailed Description

This study intended to conduct a randomized trial to determine whether LESS LAVH has a faster recovery rate than three-port LAVH.

• Study Type: Interventional
• Enrollment (Actual): 424
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient who undergo laparoscopic assisted vaginal hysterectomy due to following gynecologic disease

  1. uterine leiomyoma
  2. uterine adenomyosis
  3. Endometrial hyperplasia
  4. cervical intraepithelial neoplasia including carcinoma in situ
  5. Dysfunctional uterine bleeding
  6. Other benign gynecologic disease requiring hysterectomy
• American Society of Anesthesiologists Physical Status classification I-II
• Patient who have signed an written informed consent

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single-port LAVH group; single-port laparoscopic assisted vaginal hysterectomy	Procedure: Single-port LAVH; LESS LAVH was performed using a commercially available four-channel, single-port system. A rigid, 0-degree, 5 mm laparoscope was used.
Active Comparator: Three-port LAVH group; three-port laparoscopic assisted vaginal hysterectomy	Procedure: Three-port LAVH; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain	Postoperative pain was recorded using the Visual Analog Pain Scale (VAS), scored from 1 to 10 (0 is no pain and 10 is agonizing pain)	within 1 week after surgery
postoperative analgesics requirement	Whenever patients requested additional analgesia, they were administered parenterally.	within 1 week after surgery
operating time	skin to skin operation time was recorded	1 day (immediately ater surgery)
Transfusion requirement and amount	Transfusion requirement and amount were recorede	within 1 week after surgery
intra and postoperative complication	intra and post operative complications were recorede	within 1 months after surgery

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Joo-Hyun Nam, M.D., Ph.D., Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2012
• Primary Completion (Actual): December 12, 2018
• Study Completion (Actual): June 11, 2019

Study Registration Dates

• First Submitted: September 3, 2012
• First Submitted That Met QC Criteria: September 5, 2012
• First Posted (Estimated): September 6, 2012

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: LESS; Benign uterine disease; LAVH
• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Diseases
• Other Study ID Numbers: LESS-H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No