Comparison of Concentration of Vasopressin During Robot-assisted Laparoscopic Myomectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Uterine Leiomyoma

Intervention / Treatment
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* Drug: Vasopressin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diluted Vasopressin Group 1<br>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<br>* During robot-assisted laparoscopic myomectomy, vasopressin diluted to different concentrations will be injected before uterine serosal incision.<br>* Other names: Vasopressin 20U;|
| Active Comparator: Diluted Vasopressin Group 2<br>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<br>* During robot-assisted laparoscopic myomectomy, vasopressin diluted to different concentrations will be injected before uterine serosal incision.<br>* Other names: Vasopressin 20U;|
| Active Comparator: Diluted Vasopressin Group 3<br>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<br>* During robot-assisted laparoscopic myomectomy, vasopressin diluted to different concentrations will be injected before uterine serosal incision.<br>* Other names: Vasopressin 20U;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin | Change of serum hemoglobin from baseline | Post-op 1 day | 
| Hematocrit | Change of serum hematocrit from baseline | Post-op 1 day | 
| Operation running time | Time from anesthesia start to delivery of patient to recovery room | during operation | 
| Transfusion | 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 | The amount of fluid injected during operation | during operation | 
| Hospitalization period | Days from admission day to discharge day | Within post-op 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vasopressin, Leiomyoma, Uterine fibroid, Uterine Myomectomy, Hemostasis, Dilution