Micro-orifice metabolic/bariatric surgery under IV sedation/local anesthesia: porcine feasibility study.
BACKGROUND
As the volume and scope of metabolic/bariatric surgery increases, there is a definite trend toward the development and utilization of simpler and safer procedures. The laparoscopic approach has certain disadvantages that can be avoided by a technique for abdominal access via a micro-orifice incision under intravenous (IV) sedation/local anesthesia, without general anesthesia, insufflation, and intubation.


METHODS
In a porcine model, we used the implantation of the TANTALUS System as a prototype for the micro-orifice, IV sedation/local anesthesia approach. The study was conducted in five ex vivo stomachs, four cadavers, and six in vivo animals, the last four of which underwent surgery under IV sedation/local anesthesia.


RESULTS
Accurate implantation of electrodes was achieved in all ex vivo, cadaver, and in vivo preparations with no mucosal penetration, confirmed by examination of the open porcine stomachs. Operative time in this learning setting was 1 h 43 min in the last three operated animals. Feasibility was established for using the single incision to tunnel and construct subcutaneous pockets for the pulse generator and the charge coil. No major operative or postoperative complications occurred.


CONCLUSIONS
Using the TANTALUS System as a metabolic/bariatric surgery prototype model, this study successfully tested the feasibility of micro-orifice surgery, under IV sedation/local anesthesia. This study will be followed by human trials that may offer an alternative approach for the performance of metabolic/bariatric surgery.
Buchwald
Henry
H
Department of Surgery, University of Minnesota, MMC 290, Minneapolis, MN 55455, USA. buchw001@umn.edu
Menchaca
Hector J
HJ
Michalek
Van N
VN
Suguitani
Nestor T
NT
Singh
Harpreet
H
George
Preeta
P
Belani
Kumar G
KG
D000772:Anesthesia, Local; D000818:Animals; D050110:Bariatric Surgery; D002102:Cadaver; D016292:Procedural Sedation; D004567:Electrodes, Implanted; D005240:Feasibility Studies; D006801:Humans; D010535:Laparoscopy; D009767:Obesity, Morbid / Q000378:metabolism* / Q000601:surgery*; D013552:Swine