Abstract
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 TANTALUSTM 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 TANTALUSTM 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.
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References
Bohdjalian A, Prager G, Aviv R, et al. One-year experience with TANTALUS™: a new surgical approach to treat morbid obesity. Obes Surg. 2006;16:627–34.
Peles S, Petersen J, Aviv R, et al. Enhancement of antral contractions and vagal afferent signaling with synchronized electrical stimulation. Am J Physiol Gastrointest Liver Physiol. 2003;285:G577–85.
Aviv R, Policker S, Brody F, et al. Circadian patterns of gastric electrical and mechanical activity in dogs. Neurogastroenterol Motil. 2008;20:63–8.
Aviv R, Sanmiguel CP, Kliger A, et al. The use of gastric electrical signals for algorithm for automatic eating detection in dogs. Neurogastroenterol Motil. 2008;20:369–76.
Sanmiguel CP, Aviv R, Policker S, et al. Association between gastric electromechanical activity and satiation in dogs. Obesity. 2007;15:2958–63.
Sanmiguel CP, Haddad W, Aviv R, et al. The TANTALUS™ System for obesity: effect on gastric emptying of solids and ghrelin plasma levels. Obes Surg. 2007;17:1503–9.
Policker S, Lu H, Haddad W, et al. Electrical stimulation of the gut for the treatment of type 2 diabetes: the role of automatic eating detection. J Diabetes Sci Technol. 2008;2:906–12.
Bohdjalian A, Ludvik B, Guerci B, et al. Improvement in glycemic control by gastric electrical stimulation (TANTALUS™) in overweight subjects with type 2 diabetes. Surg Endosc. 2009;23:1955–60.
Lebovitz HE. Gastric contractility modulation in the management of type 2 diabetes. U.S. Endocrine Disease, 2007;2:39–41.
Jones Jr KB, Afram JD, Benotti PN, et al. Open versus laparoscopic Roux-en-Y gastric bypass: a comparative study of over 25,000 open cases and the major laparoscopic bariatric reported series. Obes Surg. 2006;16:721–7.
Disclosure
Dr. Buchwald is a consultant for MetaCure, Ltd., Ethicon Endo-Surgery (Johnson & Johnson), and Fulfillium, Inc.
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This work was supported by a gift from MetaCure, Ltd., manufacturer of the TANTALUS™ System.
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Buchwald, H., Menchaca, H.J., Michalek, V.N. et al. Micro-orifice Metabolic/Bariatric Surgery Under IV Sedation/Local Anesthesia. OBES SURG 20, 500–505 (2010). https://doi.org/10.1007/s11695-010-0081-7
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DOI: https://doi.org/10.1007/s11695-010-0081-7