Safety and Performance of the da Vinci SP® Surgical System in Colorectal Procedures

Study Overview
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Brief Summary
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The study is a prospective, single-center, single-arm unblinded clinical investigation. The aim of this study is to evaluate the performance and safety of da Vinci SP system. This study will entail a collection of demographics, preoperative, perioperative and postoperative outcomes of the patients into a database to follow this report on the outcomes, and notably answer questions to demonstrate the performance and safety of this surgical option. All patients being considered for minimally invasive colorectal surgery will be evaluated for participation in the above study. All of these patients will undergo a standard minimally invasive resection in the same fashion as would be carried out with multiport laparoscopic or robotic surgery

Official Title
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A Prospective, Single-Center Investigation of the Safety and Performance of the da Vinci SP® Surgical System in Colorectal Procedures

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Device: single-port robotic surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Pathological confirm of colon or rectal cancer Clinical stage I-III Patient is a candidate for minimally invasive right hemicolectomy or anterior resection. ASA ≤3 Performance status: ECOG 0-1 Exclusion Criteria: Emergency surgery Patient has metastatic disease Patient has a bleeding or clotting disorder Uncontrolled illness, including active infection, symptomatic heart failure, unstable angina or cardiac arrhythmias, or psychiatric illness that would limit compliance with study requirements Previous laparotomy history Patient unable to provide informed consent Patient is pregnant BMI 35.0 or higher

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participant arm<br> | Device: single-port robotic surgery<br>* Colorectal surgery using the da Vinci SP System will be performed via the umbilicus, McBurney's site or the reverse McBurney's site depending on the sites of lesion. All of these patients will undergo a standard minimally invasive resection in the same fashion as would be carried out with multiport laparoscopic or robotic surgery.<br>* Other names: da Vinci SP System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate (%) | Calculating the percentage of cases successfully performed using the da Vinci SP system via the SP access port with or without an additional 12mm assistant port. Conversion to laparoscopy or laparotomy will be considered as failure. | immediately after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative Parameters:Incision length | Incision length | immediately after the surgery | 
| Perioperative Parameters:Time of surgery | Time of surgery | immediately after the surgery | 
| Perioperative Parameters:Total operative time | Total operative time | immediately after the surgery | 
| Perioperative Parameters:Robotic console time | Robotic console time | immediately after the surgery | 
| Perioperative Parameters: Blood transfusions | Blood transfusion amount | immediately after the surgery | 
| Perioperative Parameters: Estimated blood loss | Estimated blood loss | immediately after the surgery | 
| Perioperative Parameters: Intra-operative Complications | Satava System | immediately after the surgery | 
| Perioperative Parameters: Urine output | Urine output | immediately after the surgery | 
| Perioperative Parameters: Type of anastomosis | How the anastomosis was performed and method of construction | immediately after the surgery | 
| Postoperative Parameters:pain requirements | type, frequency, total amount of narcotics used postoperatively per day | Within 30days after the surgery | 
| Postoperative Parameters:Pain score | NRS | Within 30days after the surgery | 
| Postoperative Parameters:Time to tolerate diets | time to tolerate clear liquids and solid food | Within 30days after the surgery | 
| Postoperative Parameters:Time to flatus | Time to flatus | Within 30days after the surgery | 
| Postoperative Parameters:Time to discharge | Time to discharge | Within 30days after the surgery | 
| Postoperative Parameters:Complications | Clavien-Dindo Classification | Within 30days after the surgery | 
| Postoperative Parameters:Readmission and reoperation rate | Readmission and reoperation rate | Within 30days after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Cancer, Robotic Surgery