A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Hepatopancreaticobiliary and Foregut Operations for Benign and Malignant Disease
NCT Number: NCT06562179
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hepatopancreaticobiliary and Foregut Operations
Interventions: DEVICE: da Vinci SP® Single-Port Robotic Surgical System
Sponsor: AdventHealth
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-14
Completion Date: 2030-06
Locations: AdventhHealth, Tampa, Florida, 33613, United States

Summary:
The purpose of this study is to collect data to evaluate safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in hepatopancreatic biliary (HPB) and Foregut operations. HPB and Foregut operations of this study consist of cholecystectomy, fundoplication, gastrectomy, distal pancreatectomy, pancreaticoduodenectomy, esophagectomy, and hepatectomy.

Primary Outcome Measures: Completion Using the planned da Vinci SP-assisted Single Port Robot., The number of subjects who completed the planned da Vinci SP-assisted operation without conversion to an alternate approach. Conversion to an alternate approach comprises conversion to open, multiport laparoscopic, multiport robotic or hand-assisted approach requiring undocking of the da Vinci SP Surgical System in order to complete the planned operation using the alternate approach., 12 months|Intraoperative and post-operative adverse events, The incidence of all intraoperative and post-operative adverse events that occur through the 24-month follow-up period., 24 months|Number of Positive resection Margins, Number of positive resection margins in patients with Malignant disease., 24 months|Number of Lymph node yield, Number of lymph node yield in patients with Malignant disease., 24 Months
Secondary Outcome Measures: Physical Status Classification, Assessment of the fitness of patient before surgery using the ASA Physical Status Score:

Class I - A patient in normal health Class II - A patient with mild systemic disease resulting in no functional limitations Class III - A patient with severe systemic disease that limits activity, but is not incapacitating Class IV - A patient with severe systemic disease that is a constant threat to life Class V - A moribund patient not likely to survive without the operation Class VI - A patient already declared brain dead whose organs are being removed for donor purposes, Pre-Operative Visit|Charlson Comorbidity Index Score, Predicts one-year mortality for patients with a range of comorbid conditions, helping the physician determine how aggressively to treat a condition.

This index score is assessed by assigning points (1,2,3 or 6) based on the likelihood of dying associated to 17 different conditions (co-morbidities). Scores are summed to provide a total score to predict mortality. Comorbidity classification is categorized as low (score ≤ 3), moderate (score 4 and 5), high (score 6 and 7), and very high comorbidity (score ≥ 8), Pre-Operative Visit|Operative Time, Measured in minutes, Intraoperative|Estimated blood loss, Measured after surgery in milliliters of blood. Estimated based on blood infusion volume during the surgery., Intraoperatively|Intraoperative complications, Incidence rate - number of intraoperatively complications during surgery., Intraoperatively|Postoperative complications, Incidence number of complications, assessed through electronic medical records (EMR) at 10 days 60 days post-surgery., 10 day, 2 months post surgery|Post surgery complications, Rate of complications collected in the electronic medical using the Clavien-Dindo classification system for grading adverse events.

Classification of surgical complications:

Grade I - Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.

Grade II - Requiring pharmacological treatment with drugs. Blood transfusions and total parenteral nutrition are also included

Grade III - Requiring surgical, endoscopic or radiological intervention Grade IIIa - Intervention not under general anesthesia Grade IIIb - Intervention under general anesthesia

Grade IV - Life threatening complication (including Central Nervous System (CNS) complications) requiring IC/ICU management Grade IVa - Single organ dysfunction (including dialysis) Grade IVb - Multiorgan dysfunction

Grade V - Death of a patient, 2 months post surgery|In-hospital mortality, Has patient expired during in-hospital stay post-surgery., 10 days post-surgery|Date of Discharge, Measured in number of days, 10 days post-surgery|Survival, Assessed through follow-up visits. Data collected through patient's chart in the electronic medical record (EMR)., 10 days, 2, months, annually through year 5|Disease reoccurrence, Review of EMR records for new diagnosis assessed at schedule visits. Measured in number of days until reoccurrence diagnosis is noted in the patients' record., 10 day, 2 month and annually through year 5|30-Day Readmission, Review of EMR records for any readmission following discharge post surgery, 30 days post surgery|30-day complications, Assessed as number of complications experienced by patient in the 30-day period post-surgery., 30 days post surgery