A Multicenter Randomized Controlled Trial of Open Versus Laparoscopic Left-sided Hepatectomy
试验速览
- 阶段
- 3 期
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Checklist of functional recovery (Questionnaire, liver function test of aspartate aminotransferase and alanine aminotransferase)
研究概览
简要总结
Open versus Laparoscopic Left-sided Hepatectomy (OLLEH) trial Multi-institutional, prospective and randomized trial in patients undergoing left sided hepatectomy through laparoscopic versus open procedure.
Primary endpoint: Functional recovery Secondary endpoint: Hospital duration, estimated blood loss, operation time, resection margin status, postoperative complication, mortality, liver function laboratory test, re-admission, quality of life, cosmesis, cost effectiveness
详细描述
Laparoscopic left-sided hepatectomy is widely performed for the treatment of various hepatic neoplasms. Many studies have reported that laparoscopic left-sided hepatectomy is safe and effective compared with open conventional left-sided hemihepatectomy. However, prospective study is rare and there is no randomized controlled trial.
The surgeons who are affiliated at a medical center in capital area of Korea launched the Open versus Laparoscopic Left-sided Hepatectomy (OLLEH) trial to verify the surgical outcome of laparoscopic left-sided hepatectomy.
Laparoscopic surgery has benefits that less wound and less pain. The hypothesis of the study is 'The laparoscopic left-sided hemihepatectomy is better than open surgery from functional recovery.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who underwent open or laparoscopic left-sided hepatectomy for benign or malignant neoplasm of the liver
- •Child-Pugh A without portal hypertension
- •No portosystemic shunt
- •No splenomegaly
- •Platelet count >100,000/ul
- •Age 18 to 80
- •Eastern Cooperative Oncology Group performance status: 0 or 1
- •American society of anesthesiology class: I or II
- •Informed consent
排除标准
- •Additional intervention to the liver (Radio Frequent Ablation, Percutaneous Ethanol. Injection Therapy or others)
- •Combined hepatectomy
- •Bile duct reconstruction
- •Intrahepatic duct stone
- •Upper abdominal laparotomy history
- •Previous hepatectomy
- •Combined operation for extrahepatic disease
- •Vulnerable population (mental retardation, pregnancy)
- •Patient who participated in other clinical trial within 6 months
研究组 & 干预措施
A (Open left-sided hepatectomy)
Open left-sided hepatectomy Laparotomy (upper midline, inverted 'L', or Benz incision) Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy
干预措施: Open left-sided hepatectomy (Procedure)
B (Laparoscopic left-sided hepatectomy)
Trocar insertion Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy
干预措施: Laparoscopic left-sided hepatectomy (Procedure)
结局指标
主要结局
Checklist of functional recovery (Questionnaire, liver function test of aspartate aminotransferase and alanine aminotransferase)
时间窗: up to 30 days
Checklist of functional recovery 1. (Questionnaire) Do you want intravenous analgesics for postoperative pain ? (Yes, No) 2. (Questionnaire) Do you have trouble to ambulate by oneself ? (Yes, No) 3. (Questionnaire) Do you have trouble to digest solid meal ? (Yes, No) 4. (Questionnaire) Do you want intravenous fluid to subside your thirsty ? (Yes, No) 5. (Liver function test) Are serum aspartate aminotransferase and alanine aminotransferase increasing ? (Yes, No) * Daily check the five item above until every item is 'No' * If all of the items are 'No', the patient is regarded as a functionally recovered state.
次要结局
- Readmission rate(up to 30 days)
- Postoperative complication(up to 30 days)
- Liver function test(up to 30 days)
- Quality of life(up to 30 days)
- Operation time(up to 30 days)
- Hospital duration(up to 30 days)
- Resection margin status(up to 30 days)
- Blood loss(up to 30 days)
- Mortality(up to 30 days)
研究者
Huisong Lee
Dr.
Ewha Womans University Mokdong Hospital