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

Insel Gruppe AG, University Hospital Bern

Status and phase

Terminated

Phase 2

Conditions

Bariatric Surgery Candidate

Treatments

Device: Senhance Surgical System from Asensus

Study type

Interventional

Funder types

Other

Identifiers

NCT05208138

STD0005853

Details and patient eligibility

About

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

Full 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).

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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