SPAROBOPAN Project (Spanish Registry of Robotic Pancreatic Surgery)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: robotic resection with Da Vinci Xi.
- Who it may be relevant to
- Registry conditions: Robotic Surgical Procedures, Pancreatic Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Proyecto SPAROBOPAN (Registro Nacional De Cirugía Róbotica Pancreática)
Overview
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.
Interventions
- Device robotic resection with Da Vinci Xi
robotic resection with Da Vinci Xi
Primary outcome measures
- Postoperative complications [Time frame: 90 postoperative days]
- Postoperative complications [Time frame: 90 postoperative days]
- Number of robotic procedures [Time frame: 1 year]
Secondary outcome measures (4)
- Experience of each group in robotic pancreatic surgery [Time frame: 1 year]
- Textbook outcome [Time frame: 1 year]
- Total survival [Time frame: 3 years]
- Disease-free survival [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- robotic pancreatic resections
- Asa I-III
- Signed informed consent
Exclusion criteria
- Less than 18 years old.
- ASA IV
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-crossover
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06899269 · 2024-089