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临床试验/CTRI/2024/07/070043
CTRI/2024/07/070043尚未招募2 期

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

Jyoti Sharma1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年7月16日最近更新:
相关药物

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

发起方
Jyoti Sharma
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Jyoti Sharma

AIIMS Delhi

研究点 (1)

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