Clinical trial NCT04874246: Comparison of Concentration of Vasopressin During Robot-assisted Laparoscopic Myomectomy
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Leiomyoma
Keywords: Leiomyoma
Uterine fibroid
Uterine Myomectomy
Hemostasis
Vasopressin
Dilution
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: CHA University
First posted: 2021-05-05
Enrollment: 39
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Estimated blood loss (EBL) during operation
timeFrame: during operation
Secondary outcomes:
measure: Hemoglobin
timeFrame: Post-op 1 day
measure: Hematocrit
timeFrame: Post-op 1 day
measure: Operation running time
timeFrame: during operation
measure: Transfusion
timeFrame: Post-op 2 days
measure: The amount of fluid injected during operation
timeFrame: during operation
measure: Hospitalization period
timeFrame: Within post-op 1 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hee Seung Kim, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee 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.