Benign or Preinvasive Uterine Disease
Conditions
Keywords
LESS, Benign uterine disease, LAVH
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.
Interventions
PROCEDURESingle-port LAVH
LESS LAVH was performed using a commercially available four-channel, single-port system. A rigid, 0-degree, 5 mm laparoscope was used.
PROCEDUREThree-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.
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| 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 |
Countries
South Korea
Outcome results
None listed