Clinical trial NCT05208138: Feasibility and Safety of Robotic Bariatric Surgery Using the SenhanceTM Surgical System
Official title: Feasibility and Safety of Robotic Bariatric Surgery Using the SenhanceTM Surgical System: a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Bariatric Surgery Candidate
Keywords: Bariatric Surgery
Robotic Surgery
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective single arm, two-stage phase II study
Primary purpose: OTHER

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 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).

Eligibility criteria: 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

Primary outcomes:
measure: Rate of intraoperative bleeding using the Senhance Surgical System in bariatric surgery
timeFrame: During operation, up to 2 hours
measure: Rate of intraoperative organ lesion using the Senhance Surgical System in bariatric surgery
timeFrame: During operation, up to 2 hours
measure: Rate of procedure interruption using the Senhance Surgical System in bariatric surgery
timeFrame: During operation, up to 2 hours
measure: Rate of postoperative bleeding using the Senhance Surgical System in bariatric surgery
timeFrame: up to 30 days postoperatively
measure: Rate of anastomotic or staple line leakage using the Senhance Surgical System in bariatric surgery
timeFrame: up to 30 days postoperatively
measure: Rate of surgical site infection using the Senhance Surgical System in bariatric surgery
timeFrame: up to 30 days postoperatively
measure: Rate of cardiovascular complication using the Senhance Surgical System in bariatric surgery
timeFrame: up to 30 days postoperatively
measure: Rate of respiratory complication using theSenhance Surgical System in bariatric surgery
timeFrame: up to 30 days postoperatively
measure: Rate of thromboembolic complication using the Senhance Surgical System in bariatric surgery
timeFrame: up to 30 days postoperatively
measure: Rate of renal complication using the Senhance Surgical System in bariatric surgery
timeFrame: up to 30 days postoperatively
Secondary outcomes:
measure: Feasibility of the Senhance Surgical System in bariatric surgery
timeFrame: During operation, up to 2 hours
measure: Feasibility of the Senhance Surgical System in bariatric surgery
timeFrame: During operation, up to 2 hours
measure: Feasibility of the Senhance Surgical System in bariatric surgery
timeFrame: During operation, up to 2 hours
measure: Feasibility of the Senhance Surgical System in bariatric surgery
timeFrame: at hospital discharge, up to 30 days
measure: Feasibility of the Senhance Surgical System in bariatric surgery
timeFrame: up to 30 days postoperatively
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital Universitätsspital Bern
Study officials:
affiliation: Inselspital Universitätsspital Bern
name: Philipp C Nett, MD
role: STUDY_DIRECTOR
References: