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Randomized Controlled Trial
. 2024 Jan-Feb;38(1):431-436.
doi: 10.21873/invivo.13456.

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)

Soo Jin Park #  1 , Joo Won Lee #  1 , Dong Won Hwang  1 , Seungmee Lee  2 , Ga Won Yim  3 , Gwonhwa Song  4 , Eun Ji Lee  5 , Hee Seung Kim  6   7
Affiliations
Randomized Controlled Trial

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)

Soo Jin Park et al. In Vivo. 2024 Jan-Feb.

Abstract

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).

Keywords: Uterine fibroids; bleeding control; robot-assisted laparoscopic myomectomy; vasopression.

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Conflict of interest statement

SJP and HSK are the Chief Technology Officer and Chief Executive Officer of Dreampac Corporation (Wonju, Republic of Korea). Moreover, SL and GWP are the Chief Executive Officer and a director of Precision Medicine for Peritoneal Metastasis Corporative (Wonju, Republic of Korea). The other Authors declare no conflict of interest in relation to this study.

Figures

Figure 1
Figure 1. Flow diagram of this randomized controlled pilot trial.
See this image and copyright information in PMC

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References

    1. Pavone D, Clemenza S, Sorbi F, Fambrini M, Petraglia F. Epidemiology and risk factors of uterine fibroids. Best Pract Res Clin Obstet Gynaecol. 2018;46:3–11. doi: 10.1016/j.bpobgyn.2017.09.004. - DOI - PubMed
    1. Tsai MC, Chang LT, Tam KW. Comparison of high-intensity focused ultrasound and conventional surgery for patients with uterine myomas: a systematic review and meta-analysis. J Minim Invasive Gynecol. 2021;28(10):1712–1724. doi: 10.1016/j.jmig.2021.06.002. - DOI - PubMed
    1. Kim HS, Kim JW, Kim MK, Chung HH, Lee TS, Jeon YT, Kim YB, Jeon HW, Yun YH, Park NH, Song YS, Kang SB. A randomized prospective trial of the postoperative quality of life between laparoscopic uterine artery ligation and laparoscopy-assisted vaginal hysterectomy for the treatment of symptomatic uterine fibroids: clinical trial design. Trials. 2009;10:8. doi: 10.1186/1745-6215-10-8. - DOI - PMC - PubMed
    1. Glaser LM, Friedman J, Tsai S, Chaudhari A, Milad M. Laparoscopic myomectomy and morcellation: A review of techniques, outcomes, and practice guidelines. Best Pract Res Clin Obstet Gynaecol. 2018;46:99–112. doi: 10.1016/j.bpobgyn.2017.09.012. - DOI - PubMed
    1. Arian SE, Munoz JL, Kim S, Falcone T. Robot-assisted laparoscopic myomectomy: current status. Robot Surg. 2017;4:7–18. doi: 10.2147/RSRR.S102743. - DOI - PMC - PubMed

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