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临床试验/NCT01258621
NCT01258621已完成不适用

Learning Curve for Laparoscopic Distal Pancreatectomy in a High-volume Hospital

Università Vita-Salute San Raffaele2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Conversion to open surgery

研究概览

简要总结

Laparoscopic distal pancreatectomy (LDP) for benign and borderline pancreatic lesions has recently becoming the treatment of choice in experienced centres. No data have been published about learning curve so far. The purpose of this study was to identify the learning curve period for performing LDP.

详细描述

Between March 2009 and August 2010 all patients with lesion of body or tail of pancreas were assessed for eligibility for LDP. Exclusion criteria were: major vessels contact in cancer patients, severe organ dysfunction, BMI > 35, and refusing laparoscopic approach. All laparoscopic procedures were carried out by the same surgical team with large experience in open pancreatic surgery. All patients were treated according to an early recovery after surgery protocol. Primary endpoint was conversion rate. Secondary endpoints were operation time, operative blood loss, postoperative morbidity, and length of stay.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • pancreatic lesion located at body or tail

排除标准

  • major vessels infiltration
  • severe organ dysfunction
  • refusing laparoscopic approach

结局指标

主要结局

Conversion to open surgery

时间窗: during surgery; 3 to 5 hours from the start of the procedure

次要结局

  • Operative Time(during surgery; 3 to 5 hours from the start of the procedure)
  • Blood loss(during surgery; 3 to 5 hours from the start of the procedure)
  • Length of Hospital Stay(Postoperative. From 0 to 30 days after discharge.)

研究者

申办方类型
Other

研究点 (2)

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