Noninferiority of Intramyometrial Vasopressin Injection Compared to Bilateral Temporary Clamping of Uterine Arteries During Laparoscopic Excision and Repair of Cesarean Scar Niche
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mean Hemoglobin Deficit Mean Hemoglobin Deficit
研究概览
简要总结
This study evaluates two methods for controlling intraoperative bleeding during laparoscopic surgery to repair a cesarean scar niche (CSN). It compares the effectiveness of intramyometrial vasopressin injection against bilateral temporary clamping of the uterine arteries using laparoscopic bulldog clips. The goal is to determine if vasopressin injection is non-inferior to arterial clamping in reducing blood loss and maintaining surgical field visibility.
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
- None
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of symptomatic CSN.
- •Scheduled for laparoscopic excision and repair.
排除标准
- •Contraindications to vasopressin (e.g., severe hypertension or cardiovascular disease).
- •Presence of other major uterine pathologies (e.g., large myomas or malignancy).
研究组 & 干预措施
Vasopressin Group (Group V)
Patients receiving intramyometrial injection of diluted vasopressin (12 mL) surrounding the niche before excision.
干预措施: Vasopressin Group (Drug)
Vasopressin Group (Group V)
Patients receiving intramyometrial injection of diluted vasopressin (12 mL) surrounding the niche before excision.
干预措施: Standard of Care (Procedure)
Uterine Artery Clamping Group (Group B)
Patients undergoing bilateral temporary uterine artery occlusion (BUAO) using laparoscopic bulldog vascular clips before niche excision.
干预措施: Bulldog Clamping Group (Procedure)
Uterine Artery Clamping Group (Group B)
Patients undergoing bilateral temporary uterine artery occlusion (BUAO) using laparoscopic bulldog vascular clips before niche excision.
干预措施: Standard of Care (Procedure)
结局指标
主要结局
Mean Hemoglobin Deficit Mean Hemoglobin Deficit
时间窗: 24 hours post-surgery.
The difference between preoperative and postoperative hemoglobin concentrations, used as a primary indicator of intraoperative blood loss.
次要结局
- Surgical Field Visibility (SFV) Score(Intraoperative)
- Total Operative Time(Intraoperative)
研究者
Bassem Mohamed Talaat Abdelaziz Ali
Assistant Professor of Obestitrics and gynecology
Zagazig University