Efficacy of Subcapsular Diluted Terlipressin Versus Placebo in Reducing Intraoperative Blood Loss During Myomectomy: A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Intraoperative Blood Loss
研究概览
简要总结
A myomectomy is a surgery to remove noncancerous growths (fibroids) from the uterus while keeping the uterus in place. This surgery can cause significant blood loss. Terlipressin is a medicine that narrows blood vessels and may help reduce bleeding.
This study will test whether injecting a diluted terlipressin solution under the outer covering of the fibroid, before it is removed, reduces the amount of blood lost during surgery, compared to an inactive solution (placebo). Women scheduled for myomectomy will be randomly assigned to receive either terlipressin or placebo. Neither the patients nor the surgical team will know which one was given until the study is finished. The main question this study will answer is how much blood is lost during surgery in each group.
详细描述
Myomectomy is frequently complicated by significant intraoperative bleeding. While vasoconstrictive and uterotonic agents such as vasopressin, carbetocin, and undiluted terlipressin have been studied for hemostasis, no prior trial has evaluated a diluted terlipressin solution administered via the subcapsular route. This study aims to address this gap by comparing 1 mg terlipressin diluted in 40 mL normal saline, injected subcapsularly, versus placebo, with intraoperative blood loss as the primary outcome
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Symptomatic uterine fibroid(s) with an indication for myomectomy, including menorrhagia, pelvic pain/pressure, or infertility
- •Largest myoma diameter between 4 and 10 cm
- •Baseline hemoglobin ≥ 9 g/dL
- •Not pregnant at the time of enrollment
- •Negative urine pregnancy test or last menstrual period within 4 weeks
- •Willing and able to provide written informed consent
排除标准
- •History of bleeding disorders or coagulopathy
- •Current anticoagulant or antiplatelet therapy
- •Known hypersensitivity or contraindication to terlipressin
- •Uncontrolled hypertension
- •Severe cardiac arrhythmia
- •Uncontrolled ischemic heart disease
- •Peripheral vascular disease
- •Pregnancy or suspected pregnancy
- •Previous myomectomy
- •Concurrent pelvic pathology requiring additional surgical intervention
- •Treatment with a GnRH agonist or ulipristal acetate within the 3 months preceding surgery
- •Suspected uterine malignancy, such as leiomyosarcoma
- •Inability to understand or provide informed consent
研究组 & 干预措施
Placebo Group
Subcapsular injection of 40 mL normal saline (no active drug), administered prior to fibroid enucleation during myomectomy
干预措施: Placebo (Drug)
Terlipressin Group
Subcapsular injection of 1 mg terlipressin diluted in 40 mL normal saline, administered prior to fibroid enucleation during myomectomy
干预措施: terlipressin (vasoconstrictor) (Drug)
结局指标
主要结局
Intraoperative Blood Loss
时间窗: Intraoperative period (from skin incision to skin closure)
Blood loss will be measured gravimetrically as the difference in weight of surgical sponges and drapes before and after use, plus the volume collected in the suction canister, minus the volume of irrigation fluid used. The result will be expressed in milliliters (mL).
次要结局
- Change in Blood Pressure(Pre-injection through 30 minutes post-injection)
- Change in Hemoglobin and Hematocrit Levels(Baseline (preoperative) to 24 hours postoperative)
- Rate of Blood Transfusion(From surgery through hospital discharge)
- Duration of Surgery(Intraoperative period)
- Requirement for Supplementary Hemostatic Intervention(Intraoperative period)
- Rate of Postoperative Complications(Through hospital discharge (and 30-day follow-up, if planned))
- Duration of Hospitalization(From the day of surgery until hospital discharge)
- Change in Heart Rate(Pre-injection through 30 minutes post-injection)
研究者
Sevil Cankaya
Obstetrics and Gynecology Specialist
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital