Comparison of Concentration of Vasopressin During Robot-assisted Laparoscopic Myomectomy
- Registration Number
- NCT04874246
- Lead Sponsor
- Seoul National University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 39
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Diluted Vasopressin Group 1 Vasopressin 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. Diluted Vasopressin Group 2 Vasopressin 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. Diluted Vasopressin Group 3 Vasopressin 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Transfusion Post-op 2 days Whether patients are transfused during admission period Number of units transfused red blood cell
Hospitalization period Within post-op 1 week Days from admission day to discharge day
Hemoglobin Post-op 1 day Change of serum hemoglobin from baseline
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
The amount of fluid injected during operation during operation The amount of fluid injected during operation
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of