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临床试验/NCT06899269
NCT06899269尚未招募不适用

Proyecto SPAROBOPAN (Registro Nacional De Cirugía Róbotica Pancreática)

Hospital General Universitario de Alicante0 个研究点目标入组 225 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
225
主要终点
Postoperative complications

研究概览

简要总结

Pancreatic robotic surgery (PRS) has moved from an almost testimonial procedure to a moment of expansion that is not yet clearly defined. In the pioneering centres, the results achieved are superior to those of open surgery. At present, it is not known how many centres perform CRP, what type of operations they perform, what percentage of the total number of pancreatic operations CRP represents and what results are obtained. The aim of our project is to establish a national multicentre registry of robotic pancreatic surgery that will allow us to answer all these questions.

Methodology: This is a one-year prospective multicentre registry involving all general and digestive surgery units in Spain that have a DaVinci robotic platform and wish to participate and perform robotic pancreatectomies.

All adult patients undergoing robotic pancreatectomy at participating Spanish centres who meet the inclusion criteria will be included. The registry will be open until 31 March 2026 to include post-operative morbidity and mortality at 90 days. The number of pancreatic surgeries performed in that centre during the same period will be counted to determine the percentage of robotic pancreatic surgery per centre. Intraoperative complications will be measured according to the Satava classification modified by Halls et al. Postoperative complications will be classified according to the Clavien-Dindo classification and the CCI (Comprehensive Complication Index). Pancreatic fistula, postoperative bleeding and delayed gastric emptying were classified according to the ISGPS classification and biliary fistula according to the ISGLS classification.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • robotic pancreatic resections
  • Asa I-III
  • Signed informed consent

排除标准

  • Less than 18 years old.

结局指标

主要结局

Postoperative complications

时间窗: 90 postoperative days

CCI® (Comprehensive Complication Index). 0-100%. 100% represents the death of the patient.

Number of robotic procedures

时间窗: 1 year

Number of robotic pancreatic procedures

次要结局

  • Experience of each group in robotic pancreatic surgery(1 year)
  • Textbook outcome(1 year)
  • Total survival(3 years)
  • Disease-free survival(3 years)

研究者

发起方
Hospital General Universitario de Alicante
申办方类型
Other
责任方
Principal Investigator
主要研究者

Candido Fernando Alcazar-Lopez

Clinical professor

Hospital General Universitario de Alicante

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