Benign Gynecologic Neoplasm
Conditions
Keywords
Advanced hemostatic devices, Advanced energy devices, Ligasure, Laparoscopic total hysterectomy, Vi-sealer
Brief summary
This study's primary goal is to compare the efficacy and safety of the novel advanced hemostatic device(AHD), Vi-Sealer, with conventional AHDs in laparoscopic total hysterectomy for patients with benign gynecologic neoplasm.
Detailed description
Vi-Sealer is a reusable advanced bipolar electrode with an interchangeable blade. This study evaluates the efficacy and safety of the Vi-Sealer by comparing it with other advanced hemostatic devices, such as Ligasure, Enseal, Thunderbeat, Harmonic scalpel, etc. The economic evaluation of the device compared with other disposable devices would also be conducted.
Interventions
DEVICEVi-Sealer
using Reusable device, Vi-Sealer
DEVICELigasure
using Ligasure
DEVICEOther AHD
Using other AHDs such as Thunderbeat, Harmonic scalpel, Caiman®, Enseal, etc. except Ligasure
Sponsors
Hyun Park
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 20 to 65 years 2. Clinically diagnosed with benign gynecologic neoplasms (eg. adenomyosis, uterine fibroids, etc.) 3. Eligible for hysterectomy 4. Signing an written consent form indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study prior to any other study-related assessments or procedure
Exclusion criteria
1. Large uterus size over 16 weeks of gestational age 2. Cervical or intraligamentary fibroids 3. Severe endometriosis (stage 3 or 4) 4. Suspected malignancy of the uterus or adnexa 5. Contraindicated for the use of energy devices (such as implantable cardioverter defibrillators, pacemakers) 6. Previous pelvic surgery ≥ 3 times 7. Not suitable for laparoscopic surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative procedure time | through study completion, an average of 1 year | Measure the time consumed from the initial skin incision to the closure of abdominal trocar sites |
| Estimated blood loss | through study completion, an average of 1 year | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated medical cost of device | within 6 weeks after intervention | Medical costs according to hemostatic instrument use |
| Device evaluation score | through study completion, an average of 1 year | Ergonomics and subjective hemostatic performances assessed by surgeons using the survey |
| Adverse events | within 6 weeks after intervention | Collect only for adverse events that have a relationship with medical devices for clinical trials |
Countries
South Korea
Contacts
Primary ContactHyun Park
Outcome results
None listed