Clinical trial · Interventional
Comparison of Concentration of Vasopressin During Robot-assisted Laparoscopic Myomectomy
Diluted VAsopressin During Robot-assisted Laparoscopic myomEctomy for dimiNishing Blood Loss According To the Dilution Concentration of Normal salINE: a Randomized Controlled Pilot Study
NCT04874246CI-TRIAL-00067529VALENTINEcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Leiomyoma | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vasopressin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Diluted Vasopressin Group 1
- description
- 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.
- interventionNames
- Drug: Vasopressin
- type
- ACTIVE_COMPARATOR
- label
- Diluted Vasopressin Group 2
- description
- 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.
- interventionNames
- Drug: Vasopressin
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDPark 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. PMID 38148064
- DERIVEDLee 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. PMID 36115677