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

Seoul National University

Status: Completed

Conditions: Uterine Leiomyoma

Treatments: Drug: Vasopressin

Study type: Interventional

Funder types: Other

Identifiers

NCT04874246

2011-107-1174

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: Female

Ages: 19 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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39 participants in 3 patient groups

Diluted Vasopressin Group 1

Active Comparator group

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.

Treatment:

Drug: Vasopressin

Diluted Vasopressin Group 2

Active Comparator group

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.

Treatment:

Drug: Vasopressin

Diluted Vasopressin Group 3

Active Comparator group

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.

Treatment:

Drug: Vasopressin