Reversible gastric restriction implant: safety and efficacy in a canine model.

Abstract

BACKGROUND: Gastric restrictive procedures are considered effective weight loss treatment for severe obesity. The aim of the study was to evaluate the efficacy and safety of a reversible implant that renders a partial restriction of stomach in a canine model. METHODS: The device was comprised of two longitudinal parallel non-compressive plates with two C-rings to create a small gastric pouch that opposed gastric distension. Three groups of non-obese mongrel dogs were included: group I (n&#x2009;=&#x2009;6) underwent surgical implant for 6 weeks, group II (n&#x2009;=&#x2009;6) underwent surgical implant for 6 weeks, followed by surgical removal of the implant and additional monitoring for 5 weeks, and group III (n&#x2009;=&#x2009;5) served as sham-operated controls for groups I and II. Food intake and body weight were monitored, and the stomachs were examined histologically postmortem. RESULTS: The average food intake was significantly decreased by 38.2% in group I as compared to group III throughout the 6 weeks of surgical implant (P&#x2009;<&#x2009;0.05). The implanted dogs showed a progressive weight loss as compared to sham, which reached 21% by the end of 6 weeks. In group II, after 5 weeks of implant removal, the body weights recovered to approximately 96% of baseline. Histological evidence of the implant site at the gastric walls revealed no significant structural changes, tissue ischemia, hemorrhage, or necrosis. CONCLUSION: Our results validate the feasibility of a reversible gastric restriction implant in a non-obese canine model, with the potential for achieving significant weight loss within 6 weeks and with no injury to the gastric wall.