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

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

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

Study Overview

• Status: Terminated
• Conditions: Bariatric Surgery Candidate
• Intervention / Treatment: Device: Senhance Surgical System from Asensus

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).

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • INSELSPITAL Universitatsspital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Bariatric operation with the Senhance surgical system	Device: Senhance Surgical System from Asensus; Bariatric operation with the Senhance Surgical System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of intraoperative bleeding using the Senhance Surgical System in bariatric surgery	Number of patients with intraoperative bleeding	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	During operation, up to 2 hours
Rate of procedure interruption using the Senhance Surgical System in bariatric surgery	Number of patients with procedure interruption	During operation, up to 2 hours
Rate of postoperative bleeding using the Senhance Surgical System in bariatric surgery	Number of patients with postoperative bleeding	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	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)	up to 30 days postoperatively
Rate of cardiovascular complication using the Senhance Surgical System in bariatric surgery	Number of patients with a cardiovascular complication	up to 30 days postoperatively
Rate of respiratory complication using theSenhance Surgical System in bariatric surgery	Number of patients with a respiratory complication	up to 30 days postoperatively
Rate of thromboembolic complication using the Senhance Surgical System in bariatric surgery	Number of patients with a thromboembolic complication	up to 30 days postoperatively
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the Senhance Surgical System in bariatric surgery	Operation time	During operation, up to 2 hours
Feasibility of the Senhance Surgical System in bariatric surgery	Docking time	During operation, up to 2 hours
Feasibility of the Senhance Surgical System in bariatric surgery	Conversion rate	During operation, up to 2 hours
Feasibility of the Senhance Surgical System in bariatric surgery	Length of hospital stay	at hospital discharge, up to 30 days
Feasibility of the Senhance Surgical System in bariatric surgery	Rehospitalisation rate	up to 30 days postoperatively

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Study Director: Philipp C Nett, MD, INSELSPITAL Universitatsspital Bern

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Actual): June 15, 2022
• Study Completion (Actual): June 15, 2022

Study Registration Dates

• First Submitted: December 27, 2021
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Bariatric Surgery; Robotic Surgery
• Other Study ID Numbers: STD0005853

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No