Diluted VAsopressin During Robot-assisted Laparoscopic myomEctomy for dimiNishing Blood Loss According To the Dilution Concentration of Normal salINE: a Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Estimated blood loss (EBL) during operation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Diluted Vasopressin Group 1
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.
干预措施: Vasopressin (Drug)
Diluted Vasopressin Group 2
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.
干预措施: Vasopressin (Drug)
Diluted Vasopressin Group 3
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.
干预措施: Vasopressin (Drug)
结局指标
主要结局
Estimated blood loss (EBL) during operation
时间窗: during operation
The volume of blood loss will be estimated by using simple visual assessment technique referring to irrigation bottle
次要结局
- Hematocrit(Post-op 1 day)
- Transfusion(Post-op 2 days)
- Hospitalization period(Within post-op 1 week)
- Hemoglobin(Post-op 1 day)
- Operation running time(during operation)
- The amount of fluid injected during operation(during operation)
研究者
Hee Seung Kim
Associate Professor
Seoul National University Hospital