Clinical-alimentary tractGastric electrical stimulation for medically refractory gastroparesis☆
Section snippets
Materials and methods
The Worldwide Antivomiting Electrical Stimulation Study, was conducted at 11 centers in the United States, Canada, and Europe in compliance with all applicable regulations of each country. Approval was obtained from the institutional review board or ethical committee of each center, and patients gave their written, informed consent before entering the trial.
Baseline demographics
Thirty-three patients from 11 centers (17 diabetic [9 male and 8 female] and 16 female idiopathic patients) from 19 to 65 years old were enrolled. The number of patients enrolled at each center varied from 1 to 13. These patients were highly symptomatic, with a median weekly vomiting frequency of 17.3 episodes per week and with mean vomiting and nausea severity scores of 3.3 and 3.5, respectively; had delayed gastric emptying at 2 and 4 hours; and met all entry criteria. Most were receiving
Discussion
The results of phase I, the double-blind study period, showed a consistently positive outcome for the combined group (significantly decreased vomiting frequency and preference for stimulation ON). The results of phase I were less compelling when each patient subgroup was examined separately (i.e., there was no significant different in vomiting frequency in either the diabetic or idiopathic subgroup and no significant difference in ON/OFF preference in the diabetic subgroup). Several factors may
Acknowledgements
The authors would like to acknowledge the following individuals who supported this study: G. Voeller, M.D., P. Eaton, R.N., and R. Werkman (University of Tennessee); Theresa Cutts, Ph.D. (University of Tennessee); Lesa Gann (University of Arkansas); C. Sninsky, M.D., and S. Fitz William, R.N. (University of Florida); R. Delcore, M.D., J. Forster, M.D., Z. Lin, M.S., G. Raju, M.D., and I. Sarosiek, M.D. (University of Kansas); G. Kaufman, M.D., L. Xu, M.D., and S. Bingaman, R.N. (Penn State
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- ☆
Supported in part by Medtronic, Inc., Portions of the study were presented in abstract form at the American Gastroenterological Association meetings in 2001 and 2002.