Efficacy of a laparoscopic gastric restrictive device in an obese canine model.
BACKGROUND
Bariatric surgery using laparoscopic techniques is the most effective treatment for morbid obesity. The objective of the study is to assess the safety and efficacy of a novel laparoscopic reversible gastric restrictive (RGR) device in a group of obese dogs. An implant was also performed in a cadaver to assess implant feasibility in a human.


METHODS
Four obese mongrel dogs were subjected to RGR implantation for 3 months followed by recovery for an additional 6 weeks after device removal. Food intake, body weight, radiographic barium imaging, and gastric endoscopy were used to monitor RGR performance before implant, after implant, and implant removal. An additional RGR laparoscopic implantation procedure was performed in a human cadaver.


RESULTS
The implanted obese dogs exhibited a significant decrease in food intake and body weight over 3 months with the RGR device. The reduction of food intake was sustained at an average of 46 % after implant and the excess weight loss reached an average of 75 % at the end of 12 weeks with recovery to approximately 78 % of baseline after 6 weeks of implant removal. Barium imaging and gastric endoscopy both confirmed passage for food through the restrictive device channel in the stomach. The RGR device was successfully implanted laparoscopically on the cadaver stomach in less than an hour.


CONCLUSIONS
The RGR device is laparoscopically deliverable and removable with effective and sustainable weight loss over a 12-week period in an obese dog model. The implant is also technically feasible in man.
Department of Biomedical Engineering, Indiana University Purdue University Indianapolis, Indianapolis, IN, 46202, USA.
Xiaomei
X
Guo
Samer G
SG
Mattar
Scott E
SE
Mimms
Jose A
JA
Navia
Ghassan S
GS
Kassab
D000818:Animals; D002102:Cadaver; D004195:Disease Models, Animal; D004285:Dogs; D004435:Eating; D005240:Feasibility Studies; D005260:Female; D015391:Gastroplasty / Q000295:instrumentation*; D006801:Humans; D010535:Laparoscopy; D008297:Male; D009765:Obesity / Q000601:surgery*; D019736:Prostheses and Implants; D019919:Prosthesis Implantation; D016896:Treatment Outcome; D015431:Weight Loss