Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
280 participants
INTERVENTIONAL
2023-01-20
2025-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Study 1 Vi-Sealer
This group of women undergoing hysterectomy is randomized to the energy device, Vi-sealer.
Vi-Sealer
using Reusable device, Vi-Sealer
Study 1 Ligasure
This group of women undergoing hysterectomy is randomized to the energy device, Ligasure.
Ligasure
using Ligasure
Study 2 Vi-sealer
This group of women undergoing hysterectomy is randomized to the energy device, Vi-sealer.
Vi-Sealer
using Reusable device, Vi-Sealer
Study 2 Other AHD
This group of women undergoing hysterectomy is randomized to energy devices other than Ligasure.
Other AHD
Using other AHDs such as Thunderbeat, Harmonic scalpel, Caiman®, Enseal, etc. except Ligasure
Interventions
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Vi-Sealer
using Reusable device, Vi-Sealer
Ligasure
using Ligasure
Other AHD
Using other AHDs such as Thunderbeat, Harmonic scalpel, Caiman®, Enseal, etc. except Ligasure
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
65 Years
FEMALE
No
Sponsors
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Hyun Park
OTHER
Responsible Party
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Hyun Park
Professor
Locations
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CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Hyun Park
Role: backup
References
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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.
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.
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.
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.
Winter ML, Mendelsohn SA. Total laparoscopic hysterectomy using the harmonic scalpel. JSLS. 1999 Jul-Sep;3(3):185-6.
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.
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.
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.
Honeck P, Wendt-Nordahl G, Bolenz C, Peters T, Weiss C, Alken P, Michel MS, Hacker A. Hemostatic properties of four devices for partial nephrectomy: a comparative ex vivo study. J Endourol. 2008 May;22(5):1071-6. doi: 10.1089/end.2007.0236.
Landman J, Kerbl K, Rehman J, Andreoni C, Humphrey PA, Collyer W, Olweny E, Sundaram C, Clayman RV. Evaluation of a vessel sealing system, bipolar electrosurgery, harmonic scalpel, titanium clips, endoscopic gastrointestinal anastomosis vascular staples and sutures for arterial and venous ligation in a porcine model. J Urol. 2003 Feb;169(2):697-700. doi: 10.1097/01.ju.0000045160.87700.32.
Timm RW, Asher RM, Tellio KR, Welling AL, Clymer JW, Amaral JF. Sealing vessels up to 7 mm in diameter solely with ultrasonic technology. Med Devices (Auckl). 2014 Jul 30;7:263-71. doi: 10.2147/MDER.S66848. eCollection 2014.
Nieboer TE, Steller CJ, Hinoul P, Maxson AJ, Schwiers ML, Miller CE, Coppus SF, Kent AS. Clinical utility of a novel ultrasonic vessel sealing device in transecting and sealing large vessels during laparoscopic hysterectomy using advanced hemostasis mode. Eur J Obstet Gynecol Reprod Biol. 2016 Jun;201:135-9. doi: 10.1016/j.ejogrb.2016.03.035. Epub 2016 Apr 14.
Sandberg EM, la Chapelle CF, van den Tweel MM, Schoones JW, Jansen FW. Laparoendoscopic single-site surgery versus conventional laparoscopy for hysterectomy: a systematic review and meta-analysis. Arch Gynecol Obstet. 2017 May;295(5):1089-1103. doi: 10.1007/s00404-017-4323-y. Epub 2017 Mar 29.
Park JY, Nho J, Cho IJ, Park Y, Kim DY, Suh DS, Kim JH, Nam JH. Laparoendoscopic single-site versus conventional laparoscopic-assisted vaginal hysterectomy for benign or pre-invasive uterine disease. Surg Endosc. 2015 Apr;29(4):890-7. doi: 10.1007/s00464-014-3747-8. Epub 2014 Aug 9.
Other Identifiers
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KGOG4009_Vi-TLH
Identifier Type: -
Identifier Source: org_study_id
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