Evaluating feasibility and safety of the Senhance Surgical System with digital laparoscopy in bariatric surgery.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
21
Bariatric operation with the Senhance Surgical System
Inselspital Universitätsspital Bern
Bern, Switzerland
Rate of intraoperative bleeding using the Senhance Surgical System in bariatric surgery
Number of patients with intraoperative bleeding
Time frame: 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
Time frame: During operation, up to 2 hours
Rate of procedure interruption using the Senhance Surgical System in bariatric surgery
Number of patients with procedure interruption
Time frame: During operation, up to 2 hours
Rate of postoperative bleeding using the Senhance Surgical System in bariatric surgery
Number of patients with postoperative bleeding
Time frame: 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
Time frame: 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)
Time frame: up to 30 days postoperatively
Rate of cardiovascular complication using the Senhance Surgical System in bariatric surgery
Number of patients with a cardiovascular complication
Time frame: up to 30 days postoperatively
Rate of respiratory complication using theSenhance Surgical System in bariatric surgery
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Number of patients with a respiratory complication
Time frame: up to 30 days postoperatively
Rate of thromboembolic complication using the Senhance Surgical System in bariatric surgery
Number of patients with a thromboembolic complication
Time frame: up to 30 days postoperatively
Rate of renal complication using the Senhance Surgical System in bariatric surgery
Number of patients with a renal complication
Time frame: up to 30 days postoperatively
Feasibility of the Senhance Surgical System in bariatric surgery
Operation time
Time frame: During operation, up to 2 hours
Feasibility of the Senhance Surgical System in bariatric surgery
Docking time
Time frame: During operation, up to 2 hours
Feasibility of the Senhance Surgical System in bariatric surgery
Conversion rate
Time frame: During operation, up to 2 hours
Feasibility of the Senhance Surgical System in bariatric surgery
Length of hospital stay
Time frame: at hospital discharge, up to 30 days
Feasibility of the Senhance Surgical System in bariatric surgery
Rehospitalisation rate
Time frame: up to 30 days postoperatively