Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, 138-736, South Korea
Completed
NCT Number: NCT01679548
Study of Laparoendoscopic Single Site Hysterectomy in Benign and Preinvasive Uterine Disease
To compare the efficacy between single-port and three-port laparoscopic assisted vaginal hysterectomy in patients with benign or preinvasive uterine disease
Completed
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Notify MeKey information
Conditions
Age range
20 year–70 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
About this study
This study intended to conduct a randomized trial to determine whether LESS LAVH has a faster recovery rate than three-port LAVH.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Single-port LAVH
ProcedureLESS LAVH was performed using a commercially available four-channel, single-port system. A rigid, 0-degree, 5 mm laparoscope was used.
Three-port LAVH
ProcedureConventional 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 outcomes
-
postoperative hospital stay
Time frame: 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 outcomes
-
postoperative pain
Time frame: 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)
-
postoperative analgesics requirement
Time frame: within 1 week after surgery
Whenever patients requested additional analgesia, they were administered parenterally.
-
operating time
Time frame: 1 day (immediately ater surgery)
skin to skin operation time was recorded
-
Transfusion requirement and amount
Time frame: within 1 week after surgery
Transfusion requirement and amount were recorede
-
intra and postoperative complication
Time frame: within 1 months after surgery
intra and post operative complications were recorede
Sponsors and collaborators
Lead sponsor
Asan Medical Center
Other
Registry information
Official study title
Prospective Randomized Comparison of Single-port and Three-port Laparoscopic Assisted Vaginal Hysterectomy
Important dates
- Study start
- 2012
- Primary completion
- 2018
- Study completion
- 2019
- First posted
- Sep 6, 2012
- Registry last updated
- Mar 25, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.