Comparison of Concentration of Vasopressin During Robot-assisted Laparoscopic Myomectomy
NCT ID: NCT04874246
Last Updated: 2023-06-26
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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COMPLETED
NA
39 participants
INTERVENTIONAL
2021-05-10
2022-12-31
Brief Summary
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Detailed Description
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Uterine fibroids are the most common tumors in women, and uterine myomectomy, which is performed as a treatment for them, is basically a high risk of bleeding and blood transfusion. A common method to reduce intraoperative bleeding is to inject diluted vasopressin into the subserosal areas of the fibroids. However, no proper level of vasopressin dilution has been determined so far, so we want to determine an effective dilution concentration of vasopressin that can minimize side effects through this clinical trial.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Diluted Vasopressin Group 1
During robot-assisted laparoscopic myomectomy, diluted vasopressin (a solution prepared by mixing 20 units of vasopressin with 50 ml of normal saline to make a total of 100 ml) was injected before uterine serosal incision.
Vasopressin
During robot-assisted laparoscopic myomectomy, vasopressin diluted to different concentrations will be injected before uterine serosal incision.
Diluted Vasopressin Group 2
During robot-assisted laparoscopic myomectomy, diluted vasopressin (a solution prepared by mixing 20 units of vasopressin with 200 ml of normal saline to make a total of 100 m) was injected before uterine serosal incision.
Vasopressin
During robot-assisted laparoscopic myomectomy, vasopressin diluted to different concentrations will be injected before uterine serosal incision.
Diluted Vasopressin Group 3
During robot-assisted laparoscopic myomectomy, diluted vasopressin (a solution prepared by mixing 20 units of vasopressin with 400 ml of normal saline to make a total of 100 m) was injected before uterine serosal incision.
Vasopressin
During robot-assisted laparoscopic myomectomy, vasopressin diluted to different concentrations will be injected before uterine serosal incision.
Interventions
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Vasopressin
During robot-assisted laparoscopic myomectomy, vasopressin diluted to different concentrations will be injected before uterine serosal incision.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age: 19-60 year-old women
* Plan of myomectomy for uterine leiomyomas
* Leiomyoma Subclassification System 2-7 (robot-assisted laparoscopic myomectomy is possible)
* American Society of Anesthesiologists Physical Status classification 1 or 2
* A person who understands the contents of the clinical trial, is cooperative with the trial, and is judged to be able to participate until the end of the study
Exclusion Criteria
* A single diameter of uterine leiomyoma is greater than 12 cm or more or multiple leiomyomas with more than five
* Suspicious disease of uterine malignancy
* Patient with has a history of pelvic surgery (cesarean section, myomectomy, etc.) and is expected to have severe pelvic adhesion
* A person who is hypersensitive or contraindicated to vasopressin
* A person who is hypersensitive or contraindicated to tranexamic acid
* Considered as inappropriate by the researcher's judgment
19 Years
60 Years
FEMALE
No
Sponsors
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CHA University
OTHER
Seoul National University Hospital
OTHER
Responsible Party
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Hee Seung Kim
Associate Professor
Principal Investigators
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Hee Seung Kim, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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References
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Park SJ, Lee JW, Hwang DW, Lee S, Yim GW, Song G, Lee EJ, Kim HS. Effect and Safety of Diluted Vasopressin Injection for Bleeding Control During Robot-assisted Laparoscopic Myomectomy in Reproductive Women With Uterine Fibroids: A Randomized Controlled Pilot Trial (VALENTINE Trial). In Vivo. 2024 Jan-Feb;38(1):431-436. doi: 10.21873/invivo.13456.
Lee EJ, Park SJ, Kim Y, Lim H, Lee S, Yim GW, Song G, Kim HS. Effect and safety of diluted vasopressin injection on bleeding during robot-assisted laparoscopic myomectomy: a protocol for a randomised controlled pilot trial. BMJ Open. 2022 Sep 17;12(9):e056145. doi: 10.1136/bmjopen-2021-056145.
Other Identifiers
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2011-107-1174
Identifier Type: -
Identifier Source: org_study_id
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