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临床试验/NCT03830593
NCT03830593已完成不适用

Is There Anything New in the Field of Large Adrenal Tumors ?

Samsun Liv Hospital2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2019年2月7日最近更新:
适应症

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

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

发起方
Samsun Liv Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehmet Necmettin Mercimek

MD

Samsun Liv Hospital

研究点 (2)

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