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

Bariatric Surgery Candidate Clinical Trial

— RoboBar  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05208138
• Other study ID #: STD0005853
• Status: Terminated
• Phase: Phase 2
• Start date: January 20, 2022
• Est. completion date: June 15, 2022

Study information

• Verified date: November 2022
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

Device:
• Senhance Surgical System from Asensus
Bariatric operation with the Senhance Surgical System

Locations

Country	Name	City	State
Switzerland	Inselspital Universitätsspital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of intraoperative bleeding using the Senhance Surgical System in bariatric surgery	Number of patients with intraoperative bleeding	During operation, up to 2 hours
Primary	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
Primary	Rate of procedure interruption using the Senhance Surgical System in bariatric surgery	Number of patients with procedure interruption	During operation, up to 2 hours
Primary	Rate of postoperative bleeding using the Senhance Surgical System in bariatric surgery	Number of patients with postoperative bleeding	up to 30 days postoperatively
Primary	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
Primary	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
Primary	Rate of cardiovascular complication using the Senhance Surgical System in bariatric surgery	Number of patients with a cardiovascular complication	up to 30 days postoperatively
Primary	Rate of respiratory complication using theSenhance Surgical System in bariatric surgery	Number of patients with a respiratory complication	up to 30 days postoperatively
Primary	Rate of thromboembolic complication using the Senhance Surgical System in bariatric surgery	Number of patients with a thromboembolic complication	up to 30 days postoperatively
Primary	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	Feasibility of the Senhance Surgical System in bariatric surgery	Operation time	During operation, up to 2 hours
Secondary	Feasibility of the Senhance Surgical System in bariatric surgery	Docking time	During operation, up to 2 hours
Secondary	Feasibility of the Senhance Surgical System in bariatric surgery	Conversion rate	During operation, up to 2 hours
Secondary	Feasibility of the Senhance Surgical System in bariatric surgery	Length of hospital stay	at hospital discharge, up to 30 days
Secondary	Feasibility of the Senhance Surgical System in bariatric surgery	Rehospitalisation rate	up to 30 days postoperatively