Bariatric Surgery Candidate
Conditions
Keywords
Bariatric Surgery, Robotic Surgery
Brief summary
Evaluating feasibility and safety of the Senhance Surgical System with digital laparoscopy in bariatric surgery.
Detailed description
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).
Interventions
DEVICESenhance Surgical System from Asensus
Bariatric operation with the Senhance Surgical System
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Prospective single arm, two-stage phase II study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of renal complication using the Senhance Surgical System in bariatric surgery | up to 30 days postoperatively | Number of patients with a renal complication |
| Rate of intraoperative bleeding using the Senhance Surgical System in bariatric surgery | During operation, up to 2 hours | Number of patients with intraoperative bleeding |
| Rate of intraoperative organ lesion using the Senhance Surgical System in bariatric surgery | During operation, up to 2 hours | Number of patients with intraoperative organ lesion |
| Rate of procedure interruption using the Senhance Surgical System in bariatric surgery | During operation, up to 2 hours | Number of patients with procedure interruption |
| Rate of postoperative bleeding using the Senhance Surgical System in bariatric surgery | up to 30 days postoperatively | Number of patients with postoperative bleeding |
| Rate of anastomotic or staple line leakage using the Senhance Surgical System in bariatric surgery | up to 30 days postoperatively | Number of patients with anastomotic or staple line leakage |
| Rate of surgical site infection using the Senhance Surgical System in bariatric surgery | up to 30 days postoperatively | Number of patients with surgical site infection (deep or superficial) |
| Rate of cardiovascular complication using the Senhance Surgical System in bariatric surgery | up to 30 days postoperatively | Number of patients with a cardiovascular complication |
| Rate of respiratory complication using theSenhance Surgical System in bariatric surgery | up to 30 days postoperatively | Number of patients with a respiratory complication |
| Rate of thromboembolic complication using the Senhance Surgical System in bariatric surgery | up to 30 days postoperatively | Number of patients with a thromboembolic complication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the Senhance Surgical System in bariatric surgery | During operation, up to 2 hours | Operation time |
Countries
Switzerland
Outcome results
None listed