Back to resultsStudy of Laparoendoscopic Single Site Hysterectomy in Benign and Preinvasive Uterine Disease
Primary Purpose
Benign or Preinvasive Uterine Disease
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Single-port LAVH
Three-port LAVH
Sponsored by
About this trial
This is an interventional treatment trial for Benign or Preinvasive Uterine Disease focused on measuring LESS, Benign uterine disease, LAVH
Eligibility Criteria
Inclusion Criteria:
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 and FIGO stage IA1 cancer
- 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
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
Sites / Locations
- Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Single-port LAVH group
Three-port LAVH group
Arm Description
single-port laparoscopic assisted vaginal hysterectomy
three-port laparoscopic assisted vaginal hysterectomy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
postoperative analgesics requirement
Whenever patients requested additional analgesia, they were administered parenterally.
operating time
skin to skin operation time was recorded
Transfusion requirement and amount
Transfusion requirement and amount were recorede
intra and postoperative complication
intra and post operative complications were recorede
Full Information
NCT ID
NCT01679548
First Posted
September 3, 2012
Last Updated
November 28, 2022
Sponsor
Asan Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01679548
Brief Title
Study of Laparoendoscopic Single Site Hysterectomy in Benign and Preinvasive Uterine Disease
Official Title
Prospective Randomized Comparison of Single-port and Three-port Laparoscopic Assisted Vaginal Hysterectomy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 2011 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
July 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign or Preinvasive Uterine Disease
Keywords
LESS, Benign uterine disease, LAVH
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
424 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single-port LAVH group
Arm Type
Experimental
Arm Description
single-port laparoscopic assisted vaginal hysterectomy
Arm Title
Three-port LAVH group
Arm Type
Active Comparator
Arm Description
three-port laparoscopic assisted vaginal hysterectomy
Intervention Type
Procedure
Intervention Name(s)
Single-port LAVH
Intervention Description
LESS LAVH was performed using a commercially available four-channel, single-port system. A rigid, 0-degree, 5 mm laparoscope was used.
Intervention Type
Procedure
Intervention Name(s)
Three-port LAVH
Intervention Description
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.
Primary Outcome Measure Information:
Title
postoperative hospital stay
Description
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.
Time Frame
within 1 week after surgery
Secondary Outcome Measure Information:
Title
postoperative pain
Description
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)
Time Frame
within 1 week after surgery
Title
postoperative analgesics requirement
Description
Whenever patients requested additional analgesia, they were administered parenterally.
Time Frame
within 1 week after surgery
Title
operating time
Description
skin to skin operation time was recorded
Time Frame
1 day (immediately ater surgery)
Title
Transfusion requirement and amount
Description
Transfusion requirement and amount were recorede
Time Frame
within 1 week after surgery
Title
intra and postoperative complication
Description
intra and post operative complications were recorede
Time Frame
within 1 months after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joo-Hyun Nam, M.D., Ph.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Study of Laparoendoscopic Single Site Hysterectomy in Benign and Preinvasive Uterine Disease
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