Diluted VAsopressin during robot-assisted Laparoscopic myomEctomy for dimiNishing blood loss according To the dilution concentration of normal salINE: a randomized controlled pilot study (VALENTINE pilot trial)
- Conditions
- Neoplasms
- Registration Number
- KCT0006225
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Background/Aim Vasopressin injected during myomectomy is known to effectively reduce bleeding but is sometimes associated with intraoperative vasoconstriction and hypertension due to systemic absorption. Although there is a growing preference for the use of diluted vasopressin, evidence of its effect and safety is still lacking. Patients and Methods We performed a randomized controlled pilot trial to evaluate the effect and safety of vasopressin diluted in a constant volume during robot-assisted laparoscopic myomectomy (RALM), where a total of 39 women with uterine fibroids were randomly assigned into the following three groups (group 1, 0.2 IU/ml; group 2, 0.1 IU/ml; group 3, 0.05 IU/ml with a total of 100 ml of normal saline). The primary endpoint was to compare estimated blood loss (EBL), and the secondary endpoints were to compare postoperative value and drop ratio of hemoglobin, operation time, transfusion, hospitalization, and complications among the three groups. Results There were no differences in the number and largest size of uterine fibroids, total weight of uterine fibroids, console time, and volumes of intravenous fluid administered during RALM among the three groups, whereas combined operation was performed more commonly in group 2 than in groups 1 and 3 (53.9% vs. 0 to 7.7%; p=0.01). The primary and secondary endpoints were also not different among the three groups. However, two patients in group 1 (15.4%) showed vasopressin-related hypertension. Conclusion Vasopressin diluted in a volume of 100 ml showed an effective hemostatic effect and safety during RALM (Trial No. NCT04874246 in ClinicalTrial.gov).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 36
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method estimated blood loss (EBL)
- Secondary Outcome Measures
Name Time Method Hemoglobin;Hematocrit;Operation running time;Transfusion;The amount of fluid injected during operation;Hospitalization period