Status:
TERMINATED
Feasibility and Safety of Robotic Bariatric Surgery Using the SenhanceTM Surgical System
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Bariatric Surgery Candidate
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- \< 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
Key Trial Info
Start Date :
January 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2022
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05208138
Start Date
January 20 2022
End Date
June 15 2022
Last Update
November 4 2022
Active Locations (1)
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1
Inselspital Universitätsspital Bern
Bern, Switzerland, 3010