robotic resection with Da Vinci Xi
Devicerobotic resection with Da Vinci Xi
NCT Number: NCT06899269
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
robotic resection with Da Vinci Xi
Time frame: 90 postoperative days
Clavien-Dindo Classification
Time frame: 90 postoperative days
CCI® (Comprehensive Complication Index). 0-100%. 100% represents the death of the patient.
Time frame: 1 year
Number of robotic pancreatic procedures
Time frame: 1 year
Questonnaire answering the number of robotic procedures in 2024.
Time frame: 1 year
Composite measure: No reintervention, no major complications, no readmission, no pancreatic leak B/C, no mortality and no prolongued hospital stay
Time frame: 3 years
survival after surgery in months
Time frame: 3 years
Time from surgery to recurrence
Hospital General Universitario de Alicante
Other
Proyecto SPAROBOPAN (Registro Nacional De Cirugía Róbotica Pancreática)
Acronym: SPAROBOPAN
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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