A Prospective, Single-Center Investigation of the da Vinc... | NCT06562179

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
da Vinci SP® Single-Port Robotic Surgical System	Experimental	This study will be separated into four stages, depending on the condition the participant is diagnosed with. Each Participant will go through (1) one operation. Stage One will include five (5) subjects who undergo cholecystectomy and five (5) subjects who undergo hiatal hernia repair with fundoplication (Nissen or Toupet) for a total of ten (10) subjects. Stage Two will include five (5) subjects who undergo gastrectomy and five (5) subjects who undergo distal pancreatectomy for a total of ten (10) subjects. Stage Three will include five (5) subjects who undergo pancreaticoduodenectomy and five (5) subjects who undergo esophagectomy for a total of ten (10) subjects. Stage Four will include five (5) subjects who undergo hepatectomy	Device: da Vinci SP® Single-Port Robotic Surgical System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
da Vinci SP® Single-Port Robotic Surgical System	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Cholecystectomy Stage 1 - Inclusion Criteria:

Patients between the ages of 18 and 80 years of age
Either male or female
BMI ≤ 26 kg/m2
ASA ≤ 3
Diagnosed with benign disease

Fundoplication Stage 1- Inclusion Criteria:

Patients diagnosed with GERD and/or hiatal hernia
Patients between the ages of 18 and 80 years of age
Either men or women
BMI ≤ 26 kg/m2
ASA ≤ 3

Gastrectomy Stage 2- Inclusion Criteria:

Patients between the ages of 18 and 80 years of age
Either men or women
BMI ≤ 26 kg/m2
ASA ≤ 3
Diagnosed with benign or relatively early malignant disease of the stomach
AJCC 8th edition T0 or T1 tumor pathology
AJCC 8th edition T2, T3, tumor pathology (following neoadjuvant therapy if necessary) at the discretion of the investigator
Free of metastatic disease

Distal Pancreatectomy Stage 2- Inclusion Criteria:

Patients between the ages of 18 and 80 years of age
Either men or women
BMI ≤ 26 kg/m2
ASA ≤ 3
Diagnosed with benign or malignant disease of the pancreas
No vascular involvement
Free of metastatic disease

Pancreaticoduodenectomy Stage 3- Inclusion Criteria:

Patients between the ages of 18 and 80 years of age
Either men or women
BMI ≤ 26 kg/m2
ASA ≤ 3
Diagnosed with benign or malignant disease of the pancreas
Diagnosed with benign or malignant distal bile duct disease
No vasculature involvement (i.e., no T4 disease, pancreatic or Stage 4a or b disease, or distal bile duct Stage 3b or 4 disease)
Free of metastatic disease

Esophagectomy Stage 3- Inclusion Criteria:

Patients between the ages of 18 and 80 years of age
Either men or women
BMI ≤ 26 kg/m2
ASA ≤ 3
Diagnosed with benign or malignant disease of the esophagus
AJCC 8th edition T0, T1a, T1b, T2 (without other indications for neoadjuvant therapy) tumor pathology
AJCC 8th edition some T2, T3, or T4a, (following neoadjuvant therapy) at the discretion of the investigator
Free of metastatic disease

Hepatectomy Stage 4- Inclusion Criteria:

Patients between the ages of 18 and 80 years of age
Either men or women
BMI ≤ 26 kg/m2
ASA ≤ 3
Diagnosed with benign or malignant disease of the liver or bile duct
Free of metastatic disease, not including metastatic disease to the liver (e.g., colorectal liver metastases)

Exclusion Criteria

Cholecystectomy Stage 1- Exclusion Criteria:

Subject requiring an emergent operation
Pregnancy or nursing
BMI > 26 kg/m2
Previous abdominal surgery
Subjects with malignant disease
Inability to provide informed consent
Contraindicated for general anesthesia or minimally invasive surgery

Fundoplication Stage 1- Exclusion Criteria:

Subject requiring an emergent operation
Pregnancy or nursing
BMI > 26 kg/m2
Previous abdominal surgery
Inability to provide informed consent
Contraindicated for general anesthesia or minimally invasive surgery

Gastrectomy Stage 2- Exclusion Criteria:

Subject requiring an emergency operation
Pregnancy or nursing
BMI > 26 kg/m2
Previous abdominal surgery
Inability to provide informed consent
Contraindicated for general anesthesia or minimally invasive surgery
AJCC 8th edition T2, T3, T4a, T4b tumor pathology (without neoadjuvant therapy unless contraindicated)
Clinical or radiological evidence of distant metastatic disease

Distal Pancreatectomy Stage 2- Exclusion Criteria:

Subject requiring an emergent operation
Pregnancy or nursing
BMI > 26 kg/m2
Previous abdominal surgery
Inability to provide informed consent
Contraindicated for general anesthesia or minimally invasive surgery
Tumor involvement with surrounding vasculature (e.g., common hepatic artery, superior mesenteric artery, superior mesenteric vein, portal vein)
Clinical or radiological evidence of metastatic disease

Pancreaticoduodenectomy Stage 3- Exclusion Criteria:

Subject requiring an emergent operation
Pregnancy or nursing
BMI > 26 kg/m2
Previous abdominal surgery
Inability to provide informed consent
Contraindicated for general anesthesia or minimally invasive surgery
Tumor involvement with surrounding vasculature (e.g., T4a for pancreatic disease: common hepatic artery, superior mesenteric artery, superior mesenteric vein, portal vein)
Tumor involvement with surrounding vasculature (e.g., T3b for bile duct disease: common hepatic artery, superior mesenteric artery, superior mesenteric vein, portal vein)
Clinical or radiological evidence of metastatic disease

Esophagectomy Stage 3- Exclusion Criteria:

Subject requiring an emergency operation
Pregnancy or nursing
BMI > 26 kg/m2
Previous abdominal surgery
Inability to provide informed consent
Contraindicated for general anesthesia or minimally invasive surgery
AJCC 8th edition T2 (in some circumstances), T3, and T4a tumor pathology (without neoadjuvant therapy)
Clinical or radiological evidence of distant metastatic disease

Hepatectomy Stage 4- Exclusion Criteria:

Subject requiring an emergency operation
Pregnancy or nursing
BMI > 26 kg/m2
Previous abdominal surgery
Inability to provide informed consent
Contraindicated for general anesthesia or minimally invasive surgery
Perihilar cholangiocarcinoma (i.e., Klatskin tumor)
Involvement of major vasculature (ex: portal vein, hepatic artery, or inferior vena cava)
Clinical or radiological evidence of metastatic disease

PubMed Identifier	Type	Citation	Retractions
31638504	Result	Rosemurgy A, Wilfong C, Craigg D, Co F, Sucandy I, Ross S. The Evolving Landscape of Esophageal Cancer: A Four-Decade Analysis. Am Surg. 2019 Sep 1;85(9):944-948.
23140831	Result	Golkar FC, Ross SB, Sperry S, Vice M, Luberice K, Donn N, Morton C, Hernandez JM, Rosemurgy AS. Patients' perceptions of laparoendoscopic single-site surgery: the cosmetic effect. Am J Surg. 2012 Nov;204(5):751-61. doi: 10.1016/j.amjsurg.2011.07.026.