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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
The da Vinci SP® Surgical System is designed to enable the performance of surgical procedures using a minimally invasive single-port approach. The system consists of a Surgeon Console, a Vision Cart, and a Patient Cart and is used with a camera, instruments, and accessories.
AdventhHealth
Tampa, Florida, United States
RECRUITINGCompletion 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.
Time frame: 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.
Time frame: 24 months
Number of Positive resection Margins
Number of positive resection margins in patients with Malignant disease.
Time frame: 24 months
Number of Lymph node yield
Number of lymph node yield in patients with Malignant disease.
Time frame: 24 Months
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
Time frame: 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)
Time frame: Pre-Operative Visit
Operative Time
Measured in minutes
Time frame: Intraoperative
Estimated blood loss
Measured after surgery in milliliters of blood. Estimated based on blood infusion volume during the surgery.
Time frame: Intraoperatively
Intraoperative complications
Incidence rate - number of intraoperatively complications during surgery.
Time frame: Intraoperatively
Postoperative complications
Incidence number of complications, assessed through electronic medical records (EMR) at 10 days 60 days post-surgery.
Time frame: 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
Time frame: 2 months post surgery
In-hospital mortality
Has patient expired during in-hospital stay post-surgery.
Time frame: 10 days post-surgery
Date of Discharge
Measured in number of days
Time frame: 10 days post-surgery
Survival
Assessed through follow-up visits. Data collected through patient's chart in the electronic medical record (EMR).
Time frame: 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.
Time frame: 10 day, 2 month and annually through year 5
30-Day Readmission
Review of EMR records for any readmission following discharge post surgery
Time frame: 30 days post surgery
30-day complications
Assessed as number of complications experienced by patient in the 30-day period post-surgery.
Time frame: 30 days post surgery
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