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

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ClinicalTrials.gov Identifier: NCT04874246
Recruitment Status : Not yet recruiting
First Posted : May 5, 2021
Last Update Posted : May 10, 2021
Sponsor:
Collaborator:
CHA University
Information provided by (Responsible Party):
Hee Seung Kim, Seoul National University Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Uterine Leiomyoma Drug: Vasopressin Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : May 10, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Uterine Fibroids

Arms and Interventions
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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 Name: 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 Name: 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 Name: Vasopressin 20U


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04874246


Contacts
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Contact: Hee Seung Kim, MD/PhD 82-2-2072-4863 bboddi0311@gmail.com
Contact: Eun Ji Lee, MD 82-2-2072-3629 happyeunji0103@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Contact: Eun Ji Lee, MD    82-2-2072-3629    happyeunji0103@gmail.com   
Contact: Hee Seung Kim, MD/PhD    82-2-2072-4863    bboddi0311@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
CHA University
Investigators
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Principal Investigator: Hee Seung Kim, MD/PhD Seoul National University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hee Seung Kim, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04874246    
Other Study ID Numbers: 2011-107-1174
First Posted: May 5, 2021    Key Record Dates
Last Update Posted: May 10, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hee Seung Kim, Seoul National University Hospital:
Leiomyoma
Uterine fibroid
Uterine Myomectomy
 Hemostasis
Vasopressin
Dilution
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
 Vasopressins
Arginine Vasopressin
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs