Pancreatic Surgery Clinical Trial
— IGOMIPSOfficial title:
Italian Registry of Minimally Invasive Pancreatic Surgery (IGOMIPS)
Assess the prevalence of minimally invasive pancreatic surgery in the country and its outcomes
Status | Recruiting |
Enrollment | 2300 |
Est. completion date | February 28, 2029 |
Est. primary completion date | February 28, 2029 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age > 18 years; - Underwent minimally invasive pancreatic surgery Exclusion Criteria: - Pregnant woman - Minor or unable to give informed consent |
Country | Name | City | State |
---|---|---|---|
Italy | Giovanni Capretti | Milan |
Lead Sponsor | Collaborator |
---|---|
Associazione Italiana per lo Studio del Pancreas |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative short-term outcomes | any complication graded according to Clavien-Dindo classification | 90 days | |
Primary | Long-term oncological outcomes | Disease recurrence or disease related death | 2 years | |
Secondary | 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 | Intraoperative | |
Secondary | Surgeon learning curve | Variation of surgical time according to the registered case-load as operating surgeon and first assistant | Intraoperative | |
Secondary | Surgeon learning curve | Variation of intraoperative blood-loss according to the registered case-load as operating surgeon and first assistant | Intraoperative | |
Secondary | Surgeon learning curve | Variation of intraoperative complications rate according to the registered case-load as operating surgeon and first assistant | Intraoperative | |
Secondary | Surgeon learning curve | Variation of conversion rate according to the registered case-load as operating surgeon and first assistant | Intraoperative |
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