Comparison of Concentration of Vasopressin During Robot-assisted Laparoscopic Myomectomy

Seoul National University Hospital39 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Uterine Leiomyoma

Interventions

VasopressinDRUG

During robot-assisted laparoscopic myomectomy, vasopressin diluted to different concentrations will be injected before uterine serosal incision.

Eligibility

Sex: FEMALEMin age: 19 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Estimated blood loss (EBL) during operation

The volume of blood loss will be estimated by using simple visual assessment technique referring to irrigation bottle

Time frame: during operation

Secondary Outcomes

Hemoglobin

Change of serum hemoglobin from baseline

Time frame: Post-op 1 day

Hematocrit

Change of serum hematocrit from baseline

Time frame: Post-op 1 day

Operation running time

Time from anesthesia start to delivery of patient to recovery room

Time frame: during operation

Transfusion

Whether patients are transfused during admission period Number of units transfused red blood cell

Time frame: Post-op 2 days

The amount of fluid injected during operation

Time frame: during operation

Hospitalization period

Days from admission day to discharge day

Time frame: Within post-op 1 week

Data from ClinicalTrials.gov

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