An open label randomized control trial to compare the outcomes with and without preoperative splenic artery embolization SAE in patients with moderate splenomegaly undergoing elective laparoscopic splenectomy undergoing elective laparoscopic splenectomy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. Median operative time
研究概览
简要总结
There is meagre evidence comparing the effect of pre operative splenic artery embolisation (SAE) with laparoscopic splenectomy (LS) alone in patients with splenomegaly. While no indication exists in mild splenomegaly, various studies have demonstrated a positive result of pre operative SAE before elective LS in patients with moderate and massive splenomegaly. This includes lesser intra operative blood loss, lesser transfusion rates and reduction in splenic size, facilitating better handling of spleen during surgery. However, the current evidence mainly comprises of observational studies with a small sample size and no experimental studies are available.
The current SAGES guidelines suggest that pre operative SAE before laparoscopic splenectomy in patients with splenomegaly should be the surgeon and patient’s shared decision and is based on low certainty evidence. Thus, this randomized control trial aims to establish the certainty and feasibility of pre operative SAE before laparoscopic splenectomy in cases of moderate splenomegaly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 15.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •All patients above 15 years of age undergoing elective splenectomy.
- •Patients giving informed consent.
- •Moderate splenomegaly.
排除标准
- •Patients with portal hypertension
- •Severe cardiopulmonary disease
- •Traumatic spleen
- •Liver cirrhosis.
结局指标
主要结局
1. Median operative time
时间窗: 1 week, 4 weeks and 12 weeks
2. Intra operative blood loss
时间窗: 1 week, 4 weeks and 12 weeks
3.Conversion to open surgery
时间窗: 1 week, 4 weeks and 12 weeks
次要结局
- Length of hospital stay, development of spleno-portal thrombosis and clinical response after splenectomy.(1 week, 4 weeks, 3 months)
研究者
Jyoti Sharma
AIIMS Delhi
