Comparison of Concentration of Vasopressin During Robot-assisted Laparoscopic Myomectomy

Uterine Leiomyoma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04874246
• Other study ID #: 2011-107-1174
• Status: Completed
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Leiomyoma

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	CHA University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated blood loss (EBL) during operation	The volume of blood loss will be estimated by using simple visual assessment technique referring to irrigation bottle	during operation
Secondary	Hemoglobin	Change of serum hemoglobin from baseline	Post-op 1 day
Secondary	Hematocrit	Change of serum hematocrit from baseline	Post-op 1 day
Secondary	Operation running time	Time from anesthesia start to delivery of patient to recovery room	during operation
Secondary	Transfusion	Whether patients are transfused during admission period Number of units transfused red blood cell	Post-op 2 days
Secondary	The amount of fluid injected during operation	The amount of fluid injected during operation	during operation
Secondary	Hospitalization period	Days from admission day to discharge day	Within post-op 1 week