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临床试验/NCT05616403
NCT05616403已完成不适用

Textbook Outcome as a Composite Outcome Measure in Laparoscopic Pancreaticoduodenectomy: a Retrospective, Observational Study

Tongji Hospital1 个研究点 分布在 1 个国家目标入组 1,029 人开始时间: 2010年1月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,029
试验地点
1
主要终点
Textbook outcome

研究概览

简要总结

This is a multicenter, retrospective, observational study. Textbook outcome is a composite outcome measure for surgical quality assessment. The aim of this study was to assess textbook outcome following laparoscopic pancreaticoduodenectomy in China, identify factors independently associated with achieving textbook outcome and analyze hospital variations regarding the textbook outcome after case-mix adjustment.

详细描述

Laparoscopic pancreaticoduodenectomy (LPD) remains one of the most complex and technically challenging procedures in pancreatic surgery, although LPD has developed rapidly worldwide in recent years. Traditionally, quality assessment of LPD has mainly focused on individual outcome measures such as morbidity, mortality, operative time, operative blood transfusion, readmission rates and length of hospital stay. However, individual outcome parameters do not reflect the multiple facets of the whole surgical procedure and do not measure actual variations among different hospitals. In this context, several outcome experts have suggested that composite measures of surgical quality may be better than individual outcome parameters to compare hospital performance. Textbook outcome (TO) is such a composite outcome measure of multiple desirable outcome metrics, which was first proposed in 2013 by Dutch colorectal surgeons in order to give a comprehensive summary of hospital performance. TO is realized when all of the desired outcome parameters are achieved following surgery and represents the optimal ("textbook") hospitalization.

Although several studies on TO in pancreatic surgery have been reported, relevant data on LPD are lacking, especially from China. The objective of this study was to assess TO among patients undergoing LPD in China, identify factors independently associated with achieving TO and analyze hospital variations regarding the TO after case-mix adjustment.

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

入选标准

  • Patients underwent laparoscopic pancreaticoduodenectomy.
  • Aged 18 to 75 years old.

排除标准

  • Peritoneal seeding or metastasis to distant sites.
  • Incomplete clinical data

结局指标

主要结局

Textbook outcome

时间窗: up to 90 days

Textbook outcome was defined as the absence of postoperative pancreatic fistula, postpancreatectomy hemorrhage, bile leakage, severe complications (Clavien-Dindo grade ≥ Ⅲ), in-hospital or 30-day mortality, and readmission within 30 days after discharge.

次要结局

未报告次要终点

研究者

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

Renyi Qin

Professor in Surgery, Chief Physician, Director of Surgical Supervision Department, Deputy Director of Institute of Hepatobiliary&Pancreatic, Director of Department of Biliary-Pancreatic Surgery

Tongji Hospital

研究点 (1)

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