跳至主要内容
临床试验/NCT01059097
NCT01059097已完成不适用

Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy in a High Volume Hospital.

Università Vita-Salute San Raffaele1 个研究点 分布在 1 个国家目标入组 610 人开始时间: 2001年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
610
试验地点
1
主要终点
Postoperative mortality after pancreaticoduodenectomy within 30 days of discharge

研究概览

简要总结

The independent impact of surgeon volume on outcome of patients undergoing pancreaticoduodenectomy in a high-volume Institution was assessed. A significant reduction of pancreatic fistula rate was found in the high-volume surgeon group in comparison with low-volume surgeon group. However, no difference between groups was found in mortality, major complications, and hospital stay.

详细描述

Objectives: To define the independent impact of surgeon volume on outcome after pancreaticoduodenectomy (PD) in a single high-volume institution.

Summary Background Data: The impact of surgeon volume on PD outcome is still controversial. So far, data available are from retrospective multi-institutional reviews, considering in-hospital mortality as the only outcome variable.

Methods: Prospectively collected data on 610 patients who underwent PD from August 2001 to August 2009 were analyzed. Cut-off value to categorize high and low-volume surgeons (HVS and LVS, respectively) was 18 PD/year. Primary endpoint was operative mortality (death within 30-day post-discharge). Secondary endpoints were morbidity, pancreatic fistula (PF) and length of stay. Demographic, clinical, and surgical variables were recorded.

研究设计

研究类型
Interventional
分配方式
Non 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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients who underwent pancreaticoduodenectomy between August 2001 and August 2009

排除标准

  • •Other type of surgery

研究组 & 干预措施

Low volume surgeons

Active Comparator

low volume surgeons performed less than 18 PD/year.

干预措施: Pancreaticoduodenectomy (Procedure)

High volume surgeons

Active Comparator

high volume surgeons performed at least 18 PD/year.

干预措施: Pancreaticoduodenectomy (Procedure)

结局指标

主要结局

Postoperative mortality after pancreaticoduodenectomy within 30 days of discharge

时间窗: 30 days after discharge

次要结局

  • Postoperative morbidity rate measuring the following complications: pancreatic fistula, biliary fistula, delayed gastric emptying, infectious complications, bleeding, cardiovascular complications, respiratory complications.(30 days post-discharge)
  • Postoperative hospital stay. Measuring the length of hospital stay.(At day of discharge)

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验