Italian Registry of Minimally Invasive Pancreatic Surgery
ConditionPancreatic Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssociazione Italiana per lo Studio del Pancreas
About this trial
Assess the prevalence of minimally invasive pancreatic surgery in the country and its outcomes
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years;
Underwent minimally invasive pancreatic surgery
Disqualifiers
Pregnant woman
Minor or unable to give informed consent
Trial population
The study will involve all patients undergoing at participating centers a pancreatic surgery performed by minimally invasive technique (e.g., laparoscopic, robotic), over the age of 18 years, capable of expressing consent to the study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Minimally invasive pancreatic surgery
Procedure/SurgeryMinimally invasive pancreatic surgery
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Postoperative short-term outcomes
any complication graded according to Clavien-Dindo classification
Time frame
90 days2
Long-term oncological outcomes
Disease recurrence or disease related death
Time frame
2 yearsSecondary outcomes
1
Rate of cases that after a minimally invasive approach had to be converted to and open approach
Intraoperative conversion to open surgery for any reason
Time frame
Intraoperative2
Surgeon learning curve
Variation of surgical time according to the registered case-load as operating surgeon and first assistant
Time frame
Intraoperative3
Surgeon learning curve
Variation of intraoperative blood-loss according to the registered case-load as operating surgeon and first assistant
Time frame
Intraoperative4
Surgeon learning curve
Variation of intraoperative complications rate according to the registered case-load as operating surgeon and first assistant
Time frame
IntraoperativeSponsors and contacts
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Source ClinicalTrials.gov