Prospective Randomized Comparison of Needlescopic Versus Conventional Laparoscopic Adrenalectomy for Unilateral Adrenal Tumors Less Than 4 cm in Diameter Among Patients With Primary Aldosteronism
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Timing that two consecutive VAS less than 3 points
研究概览
简要总结
The investigator conduct a randomized clinical trial for the needlescopic and conventional laparoscopic adrenalectomy to assess whether mini laparoscopic adrenalectomy is better than conventional laparoscopic adrenalectomy in terms of pain, complication rate , and wound cosmetics
详细描述
If the participant with unilateral PA tumor less than 4cm is willing to enter the clinical trial, he/she will be randomly assigned to two groups (conventional vs needlescopic laparoscopic adrenalectomy) in a 1:1 ratio, followed by preoperative assessement. All procedures were performed by experienced laparoscopic urologists (number of complex laparoscopic procedures > 50 cases/yr for 10 yrs). The participant were blinded to the type of surgical procedure underwent until the pain assessment was completed in the morning of the second days after surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over the age of 20 years old.
- •Primary aldosteronism with unilateral adrenal lesions smaller than 4 cm
- •Indications for laparoscopic surgery.
- •Informed consent
排除标准
- •Over 80 years old
- •Suspected adrenal malignancy or pheochromocytoma
- •Other concurrent surgery
- •Patients who underwent bilateral adrenal tumor resection at the same time
- •History of peritonitis or having undergoing major ipsilateral abdominal surgery.
- •American Society of Anesthesiologists (ASA) Class III or IV (with severe cardiovascular disease, uncontrolled hypertension, diabetes, chronic pulmonary obstructive pulmonary disease, morbid obesity (BMI > 40), dialysis patients, myocardial infarction, stroke, coronary artery disease, liver or coagulation dysfunction, etc.)
- •Opioid addiction
- •Patient have side effects from taking of acetaminophen, celecoxib or opioids
- •Acute intoxication of alcohol, sleep aids, anesthetics, centrally acting analgesics, opium or psychotropic drugs has occurred.
- •Patients using monoamine oxidase inhibitors (MAOIs) concurrently or within the past 14 days.
- •Patients with chronic pain or respiratory depression (such as chronic obstructive pulmonary disease)
结局指标
主要结局
Timing that two consecutive VAS less than 3 points
时间窗: up to 1 month postoperatively
Timing that two consecutive VAS less than 3 points after operation * The nurse for pain assessement would not know the allocation of the patient to this trial arms * Wound pain was assessed on a visual analogue scale (VAS) from 0 (none) to 10 (worst)
次要结局
- Cumulative morphine dosing(Right after adrenalectomy until the morning of post-op Day 2 ( before the wound dressing change))