Comparison of Concentration of Vasopressin During Robot-assisted Laparoscopic Myomectomy
VALENTINE
Diluted VAsopressin During Robot-assisted Laparoscopic myomEctomy for dimiNishing Blood Loss According To the Dilution Concentration of Normal salINE: a Randomized Controlled Pilot Study
1 other identifier
interventional
39
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2021
CompletedFirst Posted
Study publicly available on registry
May 5, 2021
CompletedStudy Start
First participant enrolled
May 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedJune 26, 2023
June 1, 2023
8 months
May 2, 2021
June 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Hemoglobin
Post-op 1 day
Hematocrit
Post-op 1 day
Operation running time
during operation
Transfusion
Post-op 2 days
The amount of fluid injected during operation
during operation
- +1 more secondary outcomes
Study Arms (3)
Diluted Vasopressin Group 1
ACTIVE COMPARATORDuring 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.
Diluted Vasopressin Group 2
ACTIVE COMPARATORDuring 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.
Diluted Vasopressin Group 3
ACTIVE COMPARATORDuring 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.
Interventions
During robot-assisted laparoscopic myomectomy, vasopressin diluted to different concentrations will be injected before uterine serosal incision.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- CHA Universitycollaborator
Study Sites (1)
Seoul National University Hospital
Seoul, 03080, South Korea
Related Publications (2)
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.
PMID: 38148064DERIVEDLee 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: 36115677DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hee Seung Kim, MD/PhD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 2, 2021
First Posted
May 5, 2021
Study Start
May 10, 2021
Primary Completion
December 31, 2021
Study Completion
December 31, 2022
Last Updated
June 26, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share