Uterine Leiomyoma Clinical Trial
— VALENTINEOfficial title:
Diluted VAsopressin During Robot-assisted Laparoscopic myomEctomy for dimiNishing Blood Loss According To the Dilution Concentration of Normal salINE: a Randomized Controlled Pilot Study
Verified date | June 2023 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 39 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 19 Years to 60 Years |
Eligibility | Inclusion Criteria: - Informed consent - 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: - Pregnancy or breastfeeding - 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | CHA University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Estimated blood loss (EBL) during operation | The volume of blood loss will be estimated by using simple visual assessment technique referring to irrigation bottle | during operation | |
Secondary | Hemoglobin | Change of serum hemoglobin from baseline | Post-op 1 day | |
Secondary | Hematocrit | Change of serum hematocrit from baseline | Post-op 1 day | |
Secondary | Operation running time | Time from anesthesia start to delivery of patient to recovery room | during operation | |
Secondary | Transfusion | Whether patients are transfused during admission period Number of units transfused red blood cell | Post-op 2 days | |
Secondary | The amount of fluid injected during operation | The amount of fluid injected during operation | during operation | |
Secondary | Hospitalization period | Days from admission day to discharge day | Within post-op 1 week |
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