Comparison of Concentration of Vasopressin During Robot-assisted Laparoscopic Myomectomy (VALENTINE)

June 23, 2023 updated by: Hee Seung Kim, Seoul National University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Vasopressin
During robot-assisted laparoscopic myomectomy, vasopressin diluted to different concentrations will be injected before uterine serosal incision.
Other Names:
  • Vasopressin 20U
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.
Drug: Vasopressin
During robot-assisted laparoscopic myomectomy, vasopressin diluted to different concentrations will be injected before uterine serosal incision.
Other Names:
  • Vasopressin 20U
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.
Drug: Vasopressin
During robot-assisted laparoscopic myomectomy, vasopressin diluted to different concentrations will be injected before uterine serosal incision.
Other Names:
  • Vasopressin 20U

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during operation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

CHA University

Investigators

  • Principal Investigator: Hee Seung Kim, MD/PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

May 2, 2021

First Submitted That Met QC Criteria

May 2, 2021

First Posted (Actual)

May 5, 2021

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 23, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-107-1174

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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