Feasibility and Safety of Robotic Bariatric Surgery Using the SenhanceTM Surgical System

Study Overview
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Brief Summary
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Evaluating feasibility and safety of the Senhance Surgical System with digital laparoscopy in bariatric surgery.

Detailed Description
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The introduction of laparoscopy in bariatric surgery is considered a milestone to improve postoperative outcomes in terms of less complications and shorter hospital stay. Furthermore, conversion into open surgery is associated with higher postoperative morbidity and mortality in bariatric surgery. Nevertheless, the laparoscopic technique has several drawbacks as lack of tactile feedback, limited degrees of freedom of the laparoscopic instruments, bad depth perception and limited field of view and therefore a flat learning curve. Senhance Surgical System from Asensus Surgical is an innovative robotic technique which presents haptic feedback, an eyetracker system, microinvasive surgery (with 3mm instruments), reusable instruments and a lower docking time when compared to usual robotic systems. The use of this new technology has not been systematically analysed in bariatric surgery. Nevertheless, its use is expected to be safe and efficient and may also present some advantages over conventional laparoscopic surgery. The primary endpoint of the study is the safety of this new robotic platform in bariatric surgery (intraoperative complications, postoperative morbidity, and postoperative mortality). Secondary outcome is the feasibility of this new technology in bariatric surgery (docking time, operation time, conversion rate, length of hospital stay, and rehospitalisation rate).

Official Title
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Feasibility and Safety of Robotic Bariatric Surgery Using the SenhanceTM Surgical System: a Pilot Study

Conditions
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Bariatric Surgery Candidate

Intervention / Treatment
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* Device: Senhance Surgical System from Asensus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed Consent as documented by signature (Appendix Informed Consent Form) ≥ 18 years old Capable of judgment Patient eligible for laparoscopic bariatric surgery according to the SMOB (Swiss Study Group for Morbid Obesity) -Criteria and having a bariatric operation (including Sleeve gastrectomy, Y-Roux gastric bypass, Omega-loop gastric bypass) using SenhanceTM Surgical System Exclusion Criteria: < 18 years of age Participants incapable of judgment or participants under tutelage Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, No informed consent signed Women who are pregnant High risk patients (immunosuppression, myopathy, liver cirrhosis, severe heart or lung disease, renal failure) Contra-indication for laparoscopic surgery Prior upper gastro intestinal tract operations (such as hepatobiliary, pancreatic, gastrooesophageal, anti-reflux, bariatric surgery or splenectomy except cholecystectomy) or open surgery with incision above the umbilicus

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: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective single arm, two-stage phase II study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Bariatric operation with the Senhance surgical system | Device: Senhance Surgical System from Asensus<br>* Bariatric operation with the Senhance Surgical System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of intraoperative bleeding using the Senhance Surgical System in bariatric surgery | Number of patients with intraoperative bleeding | During operation, up to 2 hours | 
| Rate of intraoperative organ lesion using the Senhance Surgical System in bariatric surgery | Number of patients with intraoperative organ lesion | During operation, up to 2 hours | 
| Rate of procedure interruption using the Senhance Surgical System in bariatric surgery | Number of patients with procedure interruption | During operation, up to 2 hours | 
| Rate of postoperative bleeding using the Senhance Surgical System in bariatric surgery | Number of patients with postoperative bleeding | up to 30 days postoperatively | 
| Rate of anastomotic or staple line leakage using the Senhance Surgical System in bariatric surgery | Number of patients with anastomotic or staple line leakage | up to 30 days postoperatively | 
| Rate of surgical site infection using the Senhance Surgical System in bariatric surgery | Number of patients with surgical site infection (deep or superficial) | up to 30 days postoperatively | 
| Rate of cardiovascular complication using the Senhance Surgical System in bariatric surgery | Number of patients with a cardiovascular complication | up to 30 days postoperatively | 
| Rate of respiratory complication using theSenhance Surgical System in bariatric surgery | Number of patients with a respiratory complication | up to 30 days postoperatively | 
| Rate of thromboembolic complication using the Senhance Surgical System in bariatric surgery | Number of patients with a thromboembolic complication | up to 30 days postoperatively | 
| Rate of renal complication using the Senhance Surgical System in bariatric surgery | Number of patients with a renal complication | up to 30 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the Senhance Surgical System in bariatric surgery | Operation time | During operation, up to 2 hours | 
| Feasibility of the Senhance Surgical System in bariatric surgery | Docking time | During operation, up to 2 hours | 
| Feasibility of the Senhance Surgical System in bariatric surgery | Conversion rate | During operation, up to 2 hours | 
| Feasibility of the Senhance Surgical System in bariatric surgery | Length of hospital stay | at hospital discharge, up to 30 days | 
| Feasibility of the Senhance Surgical System in bariatric surgery | Rehospitalisation rate | up to 30 days postoperatively | 

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