Condition: Pancreas Neoplasms · Sponsor: Hospital del Mar
Pancreatic surgery, specifically pancreatoduodenectomy (PD), is a complex procedure often required for patients with pancreatic or other periampullary cancers. In recent years, minimally invasive techniques have become more popular, especially robotic-assisted surgery. However, there are limited studies comparing robotic surgery to traditional open surgery. This is a national, multicenter study in Spain comparing the outcomes of robotic versus open pancreatoduodenectomy (PD). The main goal is to assess complications within 90 days after surgery. This study is important because it will provide evidence on which approach is safer and more effective for patients. The study follows a \*\*prospective, randomized, and multicenter design\*\*, meaning patients are assigned to either robotic or open surgery randomly, and multiple hospitals are involved. The study will include all eligible patients undergoing planned PD surgery, either by robotic or open technique. To be included in the study, patients must meet these conditions: * Be \*\*18 years or older\*\*. * Require \*\*planned PD surgery\*\*. * Sign an \*\*informed consent form\*\*. Who Cannot Participate? Patients will \*\*not\*\* be included if they: * \*\*Refuse the procedure\*\*. * Have \*\*uncertainty about vascular involvement\*\*. * Have a severe health condition classified as \*\*ASA IV\*\* (high-risk for surgery). The main outcome measured will be the \*\*Comprehensive Complication Index (CCI), a standardized way…
This description comes directly from the study's public registry record.
Benedetto Ielpo, PhD, MD, FACS, FEBS · 0034 932 48 30 00 · bielpo@hmar.cat
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| Hospital del Mar | Barcelona, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06981273