Is There Anything New in the Field of Large Adrenal Tumors ?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- hospitalization
研究概览
简要总结
Laparoscopic adrenalectomy is the treatment of choice for the benign tumor of less than 6 cm. However, this is an ongoing debate that exact cut-off value of tumor size for LA. The aim of this study was to assess whether the size of the adrenal tumor affects preoperative and postoperative outcomes in patients undergoing laparoscopic transperitoneal adrenalectomy as well as to evaluate the learning curve.
详细描述
From April 2010 to October 2018, preoperative and postoperative data of 107 patients who underwent LTA with adrenal mass were recorded prospectively and analyzed retrospectively.
The inclusion criteria were all hormonally active adrenal lesions, detection of increases in size in < 4 cm adrenal tumors on serial imaging, solitary adrenal metastases without evidence of local invasion, tumors size ≥ 4 cm, patients between the age of 18 and 80, and American Society of Anesthesiologists score (ASA) ≤ 3. The patients with adrenal masses that specified suspicion of malignancy on imaging such as local invasion, irregular tumor margins were evaluated as ineligible for LTA, and excluded in this study, were addressed to open surgery. Retroperitoneoscopic and laparoscopic partial adrenalectomies were also excluded from the study.
Totally 102 patients were included in the study. The patients were allocated according to adrenal tumor size as <6cm (group 1:76) and ≥ 6 cm (group 2: 26). The variables such as demographics, tumor size, and laterality, operation time, blood loss, per-operative and postoperative complications, length of hospital stay, final pathology result were compared between the two groups. In order to evaluate the learning curve, the patients were also classified into three consecutive groups including group A (1-25), group B (25-50), group C (51-75) and group D (76-102) according to the chronological order of their surgery. Variables including operation time, tumor size, blood loss, and hospital stay, and overall complications were used to investigate the learning curve.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •all hormonally active adrenal lesions,
- •detection of increases in size in < 4 cm adrenal tumors on serial imaging,
- •solitary adrenal metastases without evidence of local invasion,
- •tumors size ≥ 4 cm,
- •patients between the age of 18 and 80
- •American Society of Anesthesiologists score (ASA) ≤ 3.
排除标准
- •suspicion of malignancy on imaging such as local invasion, irregular tumor margins
- •Retroperitoneoscopic adrenalectomies
- •laparoscopic partial adrenalectomies
结局指标
主要结局
hospitalization
时间窗: 1 day
duration of postoperative hospital stay
Complication
时间窗: 1 day
abnormal conditions during or after surgery
Operation time
时间窗: intraoperative (minute)
time from onset to complete of operation
Blood loss
时间窗: intraoperative
amount of bleeding during surgery (milliliter)
次要结局
未报告次要终点
研究者
Mehmet Necmettin Mercimek
MD
Samsun Liv Hospital
