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Completed

NCT Number: NCT04874246

Comparison of Concentration of Vasopressin During Robot-assisted Laparoscopic Myomectomy

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vasopressin

Drug

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

Other names: Vasopressin 20U

Primary outcomes

  1. 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 outcomes

  1. Hemoglobin

    Time frame: Post-op 1 day

    Change of serum hemoglobin from baseline

  2. Hematocrit

    Time frame: Post-op 1 day

    Change of serum hematocrit from baseline

  3. Operation running time

    Time frame: during operation

    Time from anesthesia start to delivery of patient to recovery room

  4. Transfusion

    Time frame: Post-op 2 days

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

  5. The amount of fluid injected during operation

    Time frame: during operation

    The amount of fluid injected during operation

  6. Hospitalization period

    Time frame: Within post-op 1 week

    Days from admission day to discharge day

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • CHA University

Registry information

Official study title

Diluted VAsopressin During Robot-assisted Laparoscopic myomEctomy for dimiNishing Blood Loss According To the Dilution Concentration of Normal salINE: a Randomized Controlled Pilot Study

Acronym: VALENTINE

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 5, 2021
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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