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

Benign or Preinvasive Uterine Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01679548
• Other study ID #: LESS-H
• Status: Completed
• Phase: N/A
• Start date: November 23, 2012
• Est. completion date: June 11, 2019

Study information

• Verified date: March 2024
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424
• Est. completion date: June 11, 2019
• Est. primary completion date: December 12, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign or Preinvasive Uterine Disease
• Uterine Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	postoperative analgesics requirement	Whenever patients requested additional analgesia, they were administered parenterally.	within 1 week after surgery
Secondary	operating time	skin to skin operation time was recorded	1 day (immediately ater surgery)
Secondary	Transfusion requirement and amount	Transfusion requirement and amount were recorede	within 1 week after surgery
Secondary	intra and postoperative complication	intra and post operative complications were recorede	within 1 months after surgery