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临床试验/NCT06576336
NCT06576336已完成4 期

3D is Better for Adrenal: a Randomized Clinical Trial About Use of 3D Laparoscopy Versus 2D Laparoscopy in Adrenal Surgery

University of Palermo2 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2018年1月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
350
试验地点
2
主要终点
periperative surgical outcomes

研究概览

简要总结

Comparison between 2D traditional laparoscopic surgery and 3D laparoscopy for adrenal surgery.

详细描述

Laparoscopic adrenalectomy is today considered the gold standard of treatment for adrenal tumors. This technique was described for the first time by Gagner in 1992 and in the past years several studies have shown the advantages of laparoscopic approach with decrease of the perioperative morbidity, lower complication rates, less operative blood loss, less postoperative pain and shorter hospital stay compared with open adrenalectomy. Laparoscopic surgery is more difficult to learn and requires different psychomotor skills than open laparotomy. In fact, the surgeons have to work in a three-dimensional space, but are guided by two-dimensional images. The development of high definition cameras does not eliminate the major limitation of two-dimensional (2D) laparoscopy: lack of depth perception and lose of spatial orientation with potential increasing the strain for the surgeon, the risk of errors and the operative time. Three-dimensional (3D) HD laparoscopy was developed as an alternative to conventional 2D laparoscopy.

In literature there are still few clinical studies on use of 3D in laparoscopic adrenalectomies with different results.

For these reasons the investigators propose an international multicenter study to compare 3D laparoscopic adrenalectomy with standard laparoscopic adrenalectomy.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients competent to give consent
  • •aged between 18 and 85 years
  • •functioning and not functioning benign adrenal lesions,
  • •adrenal malignancies candidate to laparoscopic adrenal surgery.

排除标准

  • •open adrenal surgery
  • •preoperative signs of local periadrenal invasiveness

研究组 & 干预措施

3D group

Experimental

patients underwent to 3D laparoscopic adrenalectomy for adrenal mass.

干预措施: laparoscopic adrenalectomy (Procedure)

2D group

Active Comparator

patients underwent to 2D laparoscopic adrenalectomy for adrenal mass.

干预措施: laparoscopic adrenalectomy (Procedure)

结局指标

主要结局

periperative surgical outcomes

时间窗: 30-postoperative days

evaluation of intraoperative surgical complication during laparoscopic adrenalectomy with YES or NO and questionnaire about resolution of complications. In details the investigators evaluates: vascular complications (Major lesions: renal artery, renal vein; aorta; vena cava; sovrahepatic veins. Minor lesions: adrenal vessels; accessory renal vessels; others); complication hollow viscus (bowel; colonic; stomach; urether); complication parenchymatous viscus (renal; adrenal; spleen; diaphragm); resolution of complications; conversion to open surgery. 30-day postoperative complications (only grade 3 - 4 - 5 sec. Clavien-Dindo classification)

次要结局

  • depth perception(intraoperatory time)
  • definition of surgical plane(intraoperatory time)
  • evaluation of surgical strain(intraoperatory time)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Antonino Agrusa

Full Professor of Surgery

University of Palermo

研究点 (2)

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