About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
robotic pancreatic resections
Asa I-III
Signed informed consent
Disqualifiers
Less than 18 years old.
ASA IV
Trial population
Patient who will undergo robotic pancreatic resections
Trial design
Case-crossover
Prospective
Treatments tested in this trial
robotic resection with Da Vinci Xi
Devicerobotic resection with Da Vinci Xi
Treatment groups
Trial outcomes
Primary outcomes
Postoperative complications
Clavien-Dindo Classification
Postoperative complications
CCI® (Comprehensive Complication Index). 0-100%. 100% represents the death of the patient.
Number of robotic procedures
Number of robotic pancreatic procedures
Secondary outcomes
Experience of each group in robotic pancreatic surgery
Questonnaire answering the number of robotic procedures in 2024.
Textbook outcome
Composite measure: No reintervention, no major complications, no readmission, no pancreatic leak B/C, no mortality and no prolongued hospital stay
Total survival
survival after surgery in months
Disease-free survival
Time from surgery to recurrence
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: