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

Not Applicable

Completed

• Conditions: Benign or Preinvasive Uterine Disease
• Interventions: Procedure: Single-port LAVH; Procedure: Three-port LAVH

• Registration Number: NCT01679548
• Lead Sponsor: Asan Medical Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2012-09-03
• Study First Submitted QC: 2012-09-05
• Study First Posted: 2012-09-06
• Study Start: 2012-11-23
• Primary Completion: 2018-12-12
• Study Completion: 2019-06-11
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 424

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single-port LAVH group	Single-port LAVH	single-port laparoscopic assisted vaginal hysterectomy
Three-port LAVH group	Three-port LAVH	three-port laparoscopic assisted vaginal hysterectomy

Primary Outcome Measures

Name	Time	Method
postoperative hospital stay	within 1 week after surgery	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.

Secondary Outcome Measures

Name	Time	Method
postoperative pain	within 1 week after surgery	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)
Transfusion requirement and amount	within 1 week after surgery	Transfusion requirement and amount were recorede
intra and postoperative complication	within 1 months after surgery	intra and post operative complications were recorede
postoperative analgesics requirement	within 1 week after surgery	Whenever patients requested additional analgesia, they were administered parenterally.
operating time	1 day (immediately ater surgery)	skin to skin operation time was recorded

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of