Randomized Controlled Trial Between PRA(Posterior Retroperitoneoscopic Adrenalectomy) and LA(Laparoscopic Adrenalectomy)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Operation time
研究概览
简要总结
The purpose of this study is to compare two surgical methods of adrenalectomy. One is called PRA(posterior retroperitoneal adrenalectomy), which is performed through 3 or 4 holes at patient's back. The other is LA(laparoscopic adrenalectomy) which is performed through patient's abdominal cavity after making 3 or 4 holes in the abdomen.
详细描述
Since 1992, transabdominal LA(laparoscopic adrenalectomy) has been a standard method of adrenalectomy. This traditional method has been used widely because this procedure provides wide view of the whole abdomen which is familiar to surgeons. But due to its unique location at retroperitoneum, adrenal is still not easy to approach. So various retroperitoneal approaches were designed and adjusted. Among those, PRA(posterior retroperitoneal adrenalectomy) has showed good outcomes in many institutes. PRA facilitates direct approach to kidney and adrenal gland, and so operative time can be shortened. But there has been no randomized controlled trial between these two methods.
Therefore, as experienced surgeons in both methods, we want to practice this study.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are expected to have benign adrenal disease at preoperative exams
- •Patients who have pheochromocytoma measured less than 5cm, and the other benign adrenal tumors less than 7cm in diameter in preoperative CT scan
- •Patients who do not have previous surgery history at the interested quadrant
- •Patients who is I or II grade in ASA classification(American society of anesthesiologists' physical status classification)
- •Patients who has tolerable liver function and renal function(bilirubin<2.0mg/dl and AST, ALT, serum creatinine within twice of upper normal range, coagulation panel : within normal limit)
- •Patients whose BMI(body mass index) is less than 35
- •Patients who are supposed to have normal cognitive function
- •Patients who signed the consent paper.
排除标准
- •Patients who are expected to have malignant or metastatic adrenal tumor at preoperative exams
- •Patients who have bilateral adrenal tumors
- •Patients who have condition to undergo the other operation at the abdomen together with adrenalectomy
- •Pregnant patients
- •Patients who have active or uncontrolled infection
- •Patients who have medical problems as below
- •Uncontrollable hypertension with medication(Systolic BP>150 or diastolic BP>100)
- •Angina, congestive heart failure, acute myocardial infection
- •History of coronary angioplasty or Coronary artery bypass graft surgery
- •History of stroke, transient ischemic attack with sequela
研究组 & 干预措施
PRA
Persons who get PRA surgery.
干预措施: PRA (Procedure)
LA
Persons who get LA surgery.
干预措施: LA (Procedure)
结局指标
主要结局
Operation time
时间窗: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks
operation time will be measured by attending nerse
次要结局
- Pain sensation after surgery(Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks)
- Recovery of bowel movement(Participants will be followed the duration of hospital stay, an expected average of 5 days)
- Wound complication(Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks)
- Blood loss during operation(Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks)
- Intra-operative hemodynamic status(Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks)
研究者
Kyu Eun Lee
Assistant Professor, Department of Surgery, Seoul National University College of Medicine, Seoul, Korea
Seoul National University Hospital