Dataset Information

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).

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).

SUBMITTER: Park SJ

PROVIDER: S-EPMC10756485 | biostudies-literature | 2024 Jan-Feb

REPOSITORIES: biostudies-literature

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Publications

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).

Park Soo Jin SJ Lee Joo Won JW Hwang Dong Won DW Lee Seungmee S Yim Ga Won GW Song Gwonhwa G Lee Eun Ji EJ Kim Hee Seung HS

In vivo (Athens, Greece) 20240101 1

<h4>Background/aim</h4>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.<h4>Patients and methods</h4>We performed a randomized controlled pilot trial to evaluate the effect and safety of vasopressin diluted in a constant volume during ...[more]

PMID: 38148064

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Project description:BackgroundIn Asia, the incidence of uterine fibroids (UFs) in women is as high as 1.278%. However, there are few analyses of the prevalence and independent risk factors for bleeding and recurrence after laparoscopic myomectomy (LM). This study aimed to analyze the clinical characteristics of patients with UF and identify the independent risk factors for postoperative bleeding and recurrence after LM, so as to provide a reference basis for improving the quality of life of patients.MethodsBased on our exclusion and inclusion criteria, we retrospectively analyzed a total of 621 patients who developed UF from April 2018 to June 2021. The t-test, analysis of variance (ANOVA), and chi-square test were used to analyze the relationship between the clinical characteristics of the patients and postoperative bleeding as well as recurrence. Binary logistic regression was used to analyze the independent risk factors for the occurrence of postoperative bleeding and fibroid recurrence in patients.ResultsThe rates of postoperative bleeding and recurrence after LM for uterine fibroids were 4.5% and 7.1%, respectively. Binary logistic regression analysis showed that fibroid size [odds ratio (OR) =5.502, P=0.003], maximum fibroid type (OR =0.293, P=0.048), pathological type (OR =3.673, P=0.013), preoperative prothrombin time level (OR =1.340, P=0.003), preoperative hemoglobin level (OR =0.227, P=0.036), surgery time (OR =1.066, P=0.022), intraoperative bleeding (OR =1.145, P=0.007), and postoperative infection (OR =9.540, P=0.010) were independent risk factors for postoperative bleeding; meanwhile, body mass index (BMI) (OR =1.268, P=0.001), age of menarche (OR =0.780, P=0.013), fibroid size (OR =4.519, P=0.000), fibroid number (OR =2.381, P=0.033), maximum fibroid type (OR =0.229, P=0.001), pathological type (OR =2.963, P=0.008), preoperative delivery (OR =3.822, P=0.003), preoperative C-reactive protein (CRP) level (OR =1.162, P=0.005), intraoperative ultrasonography (OR =0.271, P=0.002), postoperative gonadotropin-releasing hormone agonist treatment (OR =2.407, P=0.029), and postoperative infection (OR =7.402, P=0.005) were independent risk factors for recurrence.ConclusionsAt present, there is still a high probability of postoperative bleeding and recurrence after LM for UF. Clinical work should pay close attention to clinical features. Adequate preoperative examination to improve surgical precision, and strengthen postoperative care and education, thus reducing the probability of postoperative bleeding and recurrence in patients.

Project description:ObjectiveTo examine the quality of life experienced by women with symptomatic uterine fibroids who had been treated with UAE in comparison to myomectomy. We report the four-year follow-up of the FEMME randomised trial. Two-year follow-up data has been previously reported.Study designPremenopausal women who had symptomatic uterine fibroids amenable to myomectomy or uterine artery embolization were recruited from 29 UK hospitals. Women were excluded if they had significant adenomyosis, any malignancy, pelvic inflammatory disease or had had a previous open myomectomy or uterine artery embolization.Participants were randomised to myomectomy or embolization in a 1:1 ratio using a minimisation algorithm. Myomectomy could be open abdominal, laparoscopic or hysteroscopic, according to clinician preference. Embolization of the uterine arteries was performed according to local practice, under fluoroscopic guidance.The primary outcome measure was the Uterine Fibroid Symptom Quality of Life questionnaire, adjusted for baseline score and reported here at four years post-randomisation. Subsequent procedures for fibroids, pregnancy and outcome were amongst secondary outcomes.Trial registration ISRCTN70772394 https://doi.org/10.1186/ISRCTN70772394.Results254 women were randomized, 127 to myomectomy (105 underwent myomectomy) and 127 to uterine artery embolization (98 underwent embolization). At four years, 67 (53%) and 81 (64%) completed UFS-QoL quality of life scores. Mean difference in the UFS-QoL at 4 years was 5.0 points (95% CI -1.4 to 11.5; p = 0.13) in favour of myomectomy. There were 15 pregnancies in the UAE group and 7 in the myomectomy group, with a cumulative pregnancy rate to four years of 15% and 6% respectively (hazard ratio: 0.48; 95% CI 0.18-1.28). The cumulative repeat procedure rate to four years was 24% in the UAE group and 13% in the myomectomy group (hazard ratio: 0.53; 95% CI 0.27-1.05).ConclusionsMyomectomy resulted in greater improvement in quality of life compared with uterine artery embolization, although by four years, this difference was not statistically significant. Missing data may limit the generalisability of this result. The numbers of women becoming pregnant were too small draw a conclusion on the effect of the procedures on fertility.

Dataset Information

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).

Background/aim

Patients and methods

Results

Conclusion

Publications

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).

Similar Datasets

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