Seoul National University Hospital
Seoul, 03080, South Korea
NCT Number: NCT04874246
The purpose of this study is to compare the effect of the concentration of vasopressin, which is used as a method for reducing blood loss in robot-assisted laparoscopic myomectomy.
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Notify Me19 year–60 year
Female
Interventional
Not applicable
Seoul, 03080, South Korea
This study is to compare the effect of the concentration of vasopressin, which is used as a method for reducing blood loss in robot-assisted laparoscopic myomectomy. We would like to evaluate the feasibility and validity of this study for future Phase III randomized clinical trials through this preliminary randomized assignment study.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
During robot-assisted laparoscopic myomectomy, vasopressin diluted to different concentrations will be injected before uterine serosal incision.
Other names: Vasopressin 20U
Time frame: during operation
The volume of blood loss will be estimated by using simple visual assessment technique referring to irrigation bottle
Time frame: Post-op 1 day
Change of serum hemoglobin from baseline
Time frame: Post-op 1 day
Change of serum hematocrit from baseline
Time frame: during operation
Time from anesthesia start to delivery of patient to recovery room
Time frame: Post-op 2 days
Whether patients are transfused during admission period Number of units transfused red blood cell
Time frame: during operation
The amount of fluid injected during operation
Time frame: Within post-op 1 week
Days from admission day to discharge day
Seoul National University Hospital
Other
Diluted VAsopressin During Robot-assisted Laparoscopic myomEctomy for dimiNishing Blood Loss According To the Dilution Concentration of Normal salINE: a Randomized Controlled Pilot Study
Acronym: VALENTINE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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