Comparison of Concentration of Vasopressin During Robot-assisted Laparoscopic Myomectomy

What Was Tested

In this not phased trial, researchers set out to test Vasopressin.

It had three arms (groups): Diluted Vasopressin Group 1 (active comparator), Diluted Vasopressin Group 2 (active comparator) and Diluted Vasopressin Group 3 (active comparator).

The registry classes the interventions as drug.

More on the Plan

The researchers 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.

Who Took Part

Enrollment: 39 actual participants took part.

It was open to women only aged from 19 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Because people in this Vasopressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Vasopressin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2021-05-10 with completion listed for 2021-12-31.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Estimated blood loss (EBL) during operation (time frame: during operation).

It also tracked 6 secondary outcomes, for example Hemoglobin, Hematocrit, Operation running time, Transfusion and The amount of fluid injected during operation.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vasopressin in 39 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Vasopressin compound page, all human trials.