Uterine Leiomyoma
Conditions
Keywords
Leiomyoma, Uterine fibroid, Uterine Myomectomy, Hemostasis, Vasopressin, Dilution
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.
Interventions
DRUGVasopressin
During robot-assisted laparoscopic myomectomy, vasopressin diluted to different concentrations will be injected before uterine serosal incision.
Sponsors
CHA University
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated blood loss (EBL) during operation | during operation | The volume of blood loss will be estimated by using simple visual assessment technique referring to irrigation bottle |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hematocrit | Post-op 1 day | Change of serum hematocrit from baseline |
| Operation running time | during operation | Time from anesthesia start to delivery of patient to recovery room |
| Hemoglobin | Post-op 1 day | Change of serum hemoglobin from baseline |
| The amount of fluid injected during operation | during operation | The amount of fluid injected during operation |
| Hospitalization period | Within post-op 1 week | Days from admission day to discharge day |
| Transfusion | Post-op 2 days | Whether patients are transfused during admission period Number of units transfused red blood cell |
Countries
South Korea
Outcome results
None listed