search
Back to results

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

Primary Purpose

Uterine Leiomyoma

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Vasopressin
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Leiomyoma focused on measuring Leiomyoma, Uterine fibroid, Uterine Myomectomy, Hemostasis, Vasopressin, Dilution

Eligibility Criteria

19 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Diluted Vasopressin Group 1

Diluted Vasopressin Group 2

Diluted Vasopressin Group 3

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hemoglobin
Change of serum hemoglobin from baseline
Hematocrit
Change of serum hematocrit from baseline
Operation running time
Time from anesthesia start to delivery of patient to recovery room
Transfusion
Whether patients are transfused during admission period Number of units transfused red blood cell
The amount of fluid injected during operation
The amount of fluid injected during operation
Hospitalization period
Days from admission day to discharge day

Full Information

First Posted
May 2, 2021
Last Updated
June 23, 2023
Sponsor
Seoul National University Hospital
Collaborators
CHA University
search

1. Study Identification

Unique Protocol Identification Number
NCT04874246
Brief Title
Comparison of Concentration of Vasopressin During Robot-assisted Laparoscopic Myomectomy
Acronym
VALENTINE
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
CHA University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Leiomyoma
Keywords
Leiomyoma, Uterine fibroid, Uterine Myomectomy, Hemostasis, Vasopressin, Dilution

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diluted Vasopressin Group 1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Diluted Vasopressin Group 2
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Diluted Vasopressin Group 3
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vasopressin
Other Intervention Name(s)
Vasopressin 20U
Intervention Description
During robot-assisted laparoscopic myomectomy, vasopressin diluted to different concentrations will be injected before uterine serosal incision.
Primary Outcome Measure Information:
Title
Estimated blood loss (EBL) during operation
Description
The volume of blood loss will be estimated by using simple visual assessment technique referring to irrigation bottle
Time Frame
during operation
Secondary Outcome Measure Information:
Title
Hemoglobin
Description
Change of serum hemoglobin from baseline
Time Frame
Post-op 1 day
Title
Hematocrit
Description
Change of serum hematocrit from baseline
Time Frame
Post-op 1 day
Title
Operation running time
Description
Time from anesthesia start to delivery of patient to recovery room
Time Frame
during operation
Title
Transfusion
Description
Whether patients are transfused during admission period Number of units transfused red blood cell
Time Frame
Post-op 2 days
Title
The amount of fluid injected during operation
Description
The amount of fluid injected during operation
Time Frame
during operation
Title
Hospitalization period
Description
Days from admission day to discharge day
Time Frame
Within post-op 1 week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee Seung Kim, MD/PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36115677
Citation
Lee EJ, Park SJ, Kim Y, Lim H, Lee S, Yim GW, Song G, Kim HS. Effect and safety of diluted vasopressin injection on bleeding during robot-assisted laparoscopic myomectomy: a protocol for a randomised controlled pilot trial. BMJ Open. 2022 Sep 17;12(9):e056145. doi: 10.1136/bmjopen-2021-056145.
Results Reference
derived

Learn more about this trial

Comparison of Concentration of Vasopressin During Robot-assisted Laparoscopic Myomectomy

We'll reach out to this number within 24 hrs