Recruiting NCT05629611
Efficacy and Safety Evaluation of Vi-sealer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vi-Sealer, Ligasure, Other AHD.
- Who it may be relevant to
- Registry conditions: Benign Gynecologic Neoplasm. Basic parameters: 20 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy and Safety Evaluation of Advanced Vessel Sealing Device (Vi-sealer)
Overview
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
- Device Vi-Sealer
using Reusable device, Vi-Sealer - Device Ligasure
using Ligasure - Device Other AHD
Using other AHDs such as Thunderbeat, Harmonic scalpel, Caiman®, Enseal, etc. except Ligasure
Primary outcome measures
- Operative procedure time [Time frame: through study completion, an average of 1 year]
- Estimated blood loss [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (3)
- Estimated medical cost of device [Time frame: within 6 weeks after intervention]
- Device evaluation score [Time frame: through study completion, an average of 1 year]
- Adverse events [Time frame: within 6 weeks after intervention]
Eligibility criteria
Inclusion criteria
- Aged 20 to 65 years
- Clinically diagnosed with benign gynecologic neoplasms (eg. adenomyosis, uterine fibroids, etc.)
- Eligible for hysterectomy
- 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
- Large uterus size over 16 weeks of gestational age
- Cervical or intraligamentary fibroids
- Severe endometriosis (stage 3 or 4)
- Suspected malignancy of the uterus or adnexa
- Contraindicated for the use of energy devices (such as implantable cardioverter defibrillators, pacemakers)
- Previous pelvic surgery ≥ 3 times
- Not suitable for laparoscopic surgery
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- CHA Bundang Medical Center — Seongnam-si
Publications
- Wong C, Goh A, Merkur H. Comparison of surgical outcomes using Gyrus PKS vs LigaSure in total laparoscopic hysterectomy: A randomised controlled trial. Aust N Z J Obstet Gynaecol. 2020 Oct;60(5):790-796. doi: 10.1111/ajo.13217. Epub 2020 Jul 29. PMID 32729141
- Holloran-Schwartz MB, Gavard JA, Martin JC, Blaskiewicz RJ, Yeung PP Jr. Single-Use Energy Sources and Operating Room Time for Laparoscopic Hysterectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2016 Jan;23(1):72-7. doi: 10.1016/j.jmig.2015.08.881. Epub 2015 Aug 28. PMID 26318400
- Janssen PF, Brolmann HA, van Kesteren PJ, Bongers MY, Thurkow AL, Heymans MW, Huirne JA. Perioperative outcomes using LigaSure compared with conventional bipolar instruments in laparoscopic hysterectomy: a randomised controlled trial. BJOG. 2011 Dec;118(13):1568-75. doi: 10.1111/j.1471-0528.2011.03089.x. Epub 2011 Sep 6. PMID 21895949
- Hasanov M, Denschlag D, Seemann E, Gitsch G, Woll J, Klar M. Bipolar vessel-sealing devices in laparoscopic hysterectomies: a multicenter randomized controlled clinical trial. Arch Gynecol Obstet. 2018 Feb;297(2):409-414. doi: 10.1007/s00404-017-4599-y. Epub 2017 Dec 8. PMID 29222641
- Winter ML, Mendelsohn SA. Total laparoscopic hysterectomy using the harmonic scalpel. JSLS. 1999 Jul-Sep;3(3):185-6. PMID 10527328
- Shiber LJ, Ginn DN, Jan A, Gaskins JT, Biscette SM, Pasic R. Comparison of Industry-Leading Energy Devices for Use in Gynecologic Laparoscopy: Articulating ENSEAL versus LigaSure Energy Devices. J Minim Invasive Gynecol. 2018 Mar-Apr;25(3):467-473.e1. doi: 10.1016/j.jmig.2017.10.006. Epub 2017 Oct 12. PMID 29032252
- Rothmund R, Kraemer B, Brucker S, Taran FA, Wallwiener M, Zubke A, Wallwiener D, Zubke W. Laparoscopic supracervical hysterectomy using EnSeal vs standard bipolar coagulation technique: randomized controlled trial. J Minim Invasive Gynecol. 2013 Sep-Oct;20(5):661-6. doi: 10.1016/j.jmig.2013.04.014. Epub 2013 Jun 20. PMID 23791399
- Lee CL, Wu KY, Huang CY, Yen CF. Comparison of LigaSure tissue fusion system and a conventional bipolar device in hysterectomy via natural orifice transluminal endoscopic surgery (NOTES): A randomized controlled trial. Taiwan J Obstet Gynecol. 2019 Jan;58(1):128-132. doi: 10.1016/j.tjog.2018.11.024. PMID 30638466
Identifiers
NCT: NCT05629611 · KGOG4009_Vi-TLH