Modified Vagus Nerve-preserving Versus Conventional Laparoscopic Splenectomy and Azygoportal Disconnection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Delayed gastric emptying
研究概览
简要总结
This study aimed to evaluate whether vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection is effective and safe, and to determine whether a reduction in the incidence of postoperative complications of the digestive system improves postoperative quality of life compared with conventional laparoscopic splenectomy and azygoportal disconnection.
详细描述
After successful screening the cases of cirrhosis of liver irrespective of the etiology who have non tumor portal vein thrombosis will be enrolled. The baseline parameter will be recorded and the patient will be randomized into either interventional (vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection) or control (conventional laparoscopic splenectomy and azygoportal disconnection) group. From postoperative day 3, all patients will receive 100 mg oral aspirin enteric-coated tablets (Bayer, Leverkusen, Germany) once daily for 1 year, low-molecular-weight heparin (CS Bio, Hebei, China) subcutaneously (4.100 IU/day) for 5 days, and 25 mg of oral dipyridamole (Henan Furen, Henan, China) thrice daily for 3 months. At months 3, 9, and 12 after operation, electron gastroscopy examination for delayed gastric emptying will be done for all patients. Postoperative complications of the digestive system (including diarrhea, epigastric fullness, bloating, nausea, and vomiting), liver and renal function, and body weight will be recorded at the seventh day, months 1, 3, 6, 9, and 12 after operation. Then one year monitoring will be done in the both groups as per the primary or secondary 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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
- •Splenomegaly with secondary hypersplenism
- •Bleeding portal hypertension
- •No evidence of portal vein system thrombosis by ultrasound evaluation and angio-CT
- •Informed consent to participate in the study
排除标准
- •Delayed gastric emptying
- •Hepatocellular carcinoma or any other malignancy,
- •Hypercoagulable state other than the liver disease related
- •DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.
- •Child - Pugh C
- •Recent peptic ulcer disease
- •History of Hemorrhagic stroke
- •Pregnancy.
- •Uncontrolled Hypertension
- •Age>75 yrs
- •Human immunodeficiency virus (HIV) infection
结局指标
主要结局
Delayed gastric emptying
时间窗: 1 year
Proportions of patients who will suffer from delayed gastric emptying in both groups.
次要结局
- Portal vein system thrombosis(1 year)
- Overall survival(1 year)
- Body weight(1 year)
- Hepatic decompensation(1 year)
- Postoperative complications of the digestive system(1 year)
- Hepatocellular carcinoma(1 year)
研究者
Guo-Qing Jiang
Clinical Professor
Yangzhou University
