Posterior Retroperitoneoscopic Approach Versus Transperitoneal Laparoscopic Approach in Management of Adrenal Tumors: A Randomized Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 3
- 主要终点
- Mean operative time
研究概览
简要总结
This randomized comparative study assesses the safety and efficacy of the posterior retroperitoneoscopic adrenalectomy in comparison to the standard, anterior transperitoneal approach and suppose that this new technique is a safe and effective alternative to the standard approach.
详细描述
Aim of the study:
To upgrade the urosurgical care level for candidate of surgical adrenalectomy due to adrenal diseases, to increase efficacy of the procedure and shorten the operative time and duration of hospital stay and convalescence.
Study Objective:
Comparing the safety and efficacy of posterior retroperitoneoscopic versus anterior transperitoneal adrenalectomy, as regard to the operative time, estimated intraoperative blood loss, days of postoperative hospital stay, and rate of complications.
Study Question:
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
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients have one or more of the following;
- •Functioning adrenal adenoma,
- •Nonfunctioning adenoma < 7 cm by pelvi-abdominal CT,
- •Secondary metastatic adrenal mass suitable for laparoscopic adrenalectomy,
- •Adrenal hyperplasia indicated for laparoscopic adrenalectomy.
排除标准
- •Patients with cardiovascular disease (as angina, acute myocardial infection, congestive heart failure); history of stroke, transient myocardial attacks, coronary angioplasty or coronary artery bypass graft surgery, or any other contraindication for laparoscopy e.g. COPD,
- •Pregnant females,
- •Locally advanced malignant disease,
- •Evidence of regional lymph node involvement,
- •Vascular malignant invasion,
- •Malignant uncontrolled hypertension with pheochromocytoma,
- •Need for other simultaneous surgical intervention at the same session e.g. cholecystectomy.
结局指标
主要结局
Mean operative time
时间窗: 1 year
total time from the first abdominal incision to the last suture, and the time elapsed to identify the adrenal vein, a critical step at the operation.
Mean amount of intraoperative blood loss
时间窗: 1 year
measured in milliliters.
Mean days of postoperative hospital stay
时间窗: 1 year
include the number of days to full diet, to mobilization and to complete recovery; i.e. return to usual daily activity.
Rate of complications
时间窗: 1.5 year
classified by Clavien-Dindo classification system
次要结局
- mean of scar cosmetic assessment score(1.1 year)
- Mean of postoperative pain score(1 year)
研究者
Ahmed Mohamed Bakr Arabi
Demonstrator
Suez Canal University