SPAROBOPAN Project (Spanish Registry of Robotic Pancreatic Surgery) (SPAROBOPAN)
Proyecto SPAROBOPAN (Registro Nacional De Cirugía Róbotica Pancreática)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- robotic pancreatic resections
- Asa I-III
- Signed informed consent
Exclusion Criteria:
- Less than 18 years old.
- ASA IV
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Duoneopancreatectomy
Resection of the head of the pancreas
|
robotic resection with Da Vinci Xi
|
|
Distal pancreatectomy
Resection of the body and the tail of the pancreas
|
robotic resection with Da Vinci Xi
|
|
Total pancreatectomy
Total removal of the pancreas
|
robotic resection with Da Vinci Xi
|
|
central pancreatectomy
body or neck of the pancreas resection
|
robotic resection with Da Vinci Xi
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative complications
Time Frame: 90 postoperative days
|
Clavien-Dindo Classification
|
90 postoperative days
|
|
Postoperative complications
Time Frame: 90 postoperative days
|
CCI® (Comprehensive Complication Index).
0-100%.
100% represents the death of the patient.
|
90 postoperative days
|
|
Number of robotic procedures
Time Frame: 1 year
|
Number of robotic pancreatic procedures
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Experience of each group in robotic pancreatic surgery
Time Frame: 1 year
|
Questonnaire answering the number of robotic procedures in 2024.
|
1 year
|
|
Textbook outcome
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
|
1 year
|
|
Total survival
Time Frame: 3 years
|
survival after surgery in months
|
3 years
|
|
Disease-free survival
Time Frame: 3 years
|
Time from surgery to recurrence
|
3 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-089
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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