Novel Robotic Surgical System for Minimally Invasive Surgery

Study Overview
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Brief Summary
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This is a prospective single center cohort study on effect of a novel robotic surgical system for performance of minimally invasive surgery in multiple specialties. The targeted procedures include Urological, upper and lower GI robotic surgeries and the expected sample size will be 20 patients. The clinical outcomes for assessment include background demographics, operative time, perioperative complications as well as completion rate of procedure, hospital stay and recovery.

Detailed Description
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This is a prospective single center cohort study on effect of a novel robotic surgical system for performance of minimally invasive surgery in multiple specialties. The targeted procedures include Urological, upper and lower GI robotic surgeries and the expected sample size will be 20 patients. The procedures will be standardized according to previously reported. The diseases for robotic surgical treatment will include prostate carcinoma, colorectal carcinoma, as well as esophageal hiatal diseases and gastric carcinoma. The clinical outcomes for assessment include background demographics, operative time, perioperative complications as well as completion rate of procedure, hospital stay and recovery.

Official Title
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A Novel Robotic Surgical System for Minimally Invasive Surgery: A Prospective, Single Center, Multi-speciality Study

Conditions
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Robotic Surgery

Intervention / Treatment
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* Device: K2 Robotic Surgical System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index <35 kg/m2 Suitable for the listed minimally invasive surgical procedures for treatment of respective diseases Willingness to participate as demonstrated by giving informed consent Exclusion Criteria: Contraindication to general anesthesia Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention Untreated active infection Noncorrectable coagulopathy Presence of another malignancy or distant metastasis Emergency surgery Vulnerable population (e.g. mentally disabled, pregnancy)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Robotic Surgery<br>Prospective single arm study to investigate effect of a novel robotic surgical system on safety, efficacy and outcomes for performance of minimally invasive surgery across urology, upper and lower GI surgery. | Device: K2 Robotic Surgical System<br>* The K2 Robotic Surgical System is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery in the thorax and abdomen. The K2 Robotic Surgical System consists of a Surgeon Console [SGC], a Patient Side Robot [PSR], and a Vision Cart [VCT], and is used with an endoscope, Surgical Instruments [SGI], and Accessories [ACC]. The surgeon views the three-dimensional endoscopic image on a High-Resolution Stereo Viewer (3D Viewer), which provides a view of the abdominal cavity and surgical instrumentation, along with icons and other user interface features.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of conversion to ordinary laparoscopic surgery of robotic surgical procedures performed using the novel K2 Robotic Surgical System | Rate of conversion to ordinary laparoscopic surgery of robotic surgical procedures performed using the novel K2 Robotic Surgical System is defined as the need to change to laparoscopic surgery during the procedure. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of perioperative complications | intraoperative complications and all complications occurring during the hospital stay or within 30 days after discharge will be graded according to the Clavien-Dindo classification | 30 days | 
| intraoperative time | Intraoperative Time | 30 days | 
| Blood Loss | Amount of blood loss in mls | 30 days | 
| Pain scores on a visual analog scale | Pain score in visual analog scale scoring system (minimum 0 and maxium 10, higher score represents more pain) | 30 days | 
| Analgesic requirement | Total dose of analgesic (Pethidine) used | 30 days | 
| Length of Hospital Stay | Days after surgery | 30 days |