Comparison of Concentration of Vasopressin During Robot-assisted Laparoscopic Myomectomy

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 31, 2021

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.

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Diluted Vasopressin Group 1
    • During robot-assisted laparoscopic myomectomy, diluted vasopressin (a solution prepared by mixing 20 units of vasopressin with 50 ml of normal saline to make a total of 100 ml) was injected before uterine serosal incision.
  • Active Comparator: Diluted Vasopressin Group 2
    • During robot-assisted laparoscopic myomectomy, diluted vasopressin (a solution prepared by mixing 20 units of vasopressin with 200 ml of normal saline to make a total of 100 m) was injected before uterine serosal incision.
  • Active Comparator: Diluted Vasopressin Group 3
    • During robot-assisted laparoscopic myomectomy, diluted vasopressin (a solution prepared by mixing 20 units of vasopressin with 400 ml of normal saline to make a total of 100 m) was injected before uterine serosal incision.

Clinical Trial Outcome Measures

Primary Measures

  • Estimated blood loss (EBL) during operation
    • Time Frame: during operation
    • The volume of blood loss will be estimated by using simple visual assessment technique referring to irrigation bottle

Secondary Measures

  • Hemoglobin
    • Time Frame: Post-op 1 day
    • Change of serum hemoglobin from baseline
  • Hematocrit
    • Time Frame: Post-op 1 day
    • Change of serum hematocrit from baseline
  • Operation running time
    • Time Frame: during operation
    • Time from anesthesia start to delivery of patient to recovery room
  • Transfusion
    • Time Frame: Post-op 2 days
    • Whether patients are transfused during admission period Number of units transfused red blood cell
  • The amount of fluid injected during operation
    • Time Frame: during operation
    • The amount of fluid injected during operation
  • Hospitalization period
    • Time Frame: Within post-op 1 week
    • Days from admission day to discharge day

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 19 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Collaborator
    • CHA University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hee Seung Kim, Associate Professor – Seoul National University Hospital
  • Overall Official(s)
    • Hee Seung Kim, MD/PhD, Principal Investigator, Seoul National University Hospital

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