ABSTRACT
BACKGROUND: Gastroparesis is a disabling, and sometimes fatal, disease that often does not respond to medical treatment. This single-surgeon prospective study examines the safety and 6-month efficacy of electrical stimulation for the treatment of gastroparesis. METHODS: Sixteen patients with medically refractory gastroparesis underwent laparoscopic implantation of an electrical stimulator device (Enterra Therapy, Medtronic, Minneapolis, MN, USA) consisting of a subcutaneous stimulator and two gastric wall leads. Gastric emptying scans (GES) confirmed the diagnosis of gastroparesis. Patients were evaluated preoperatively using a self-administered GI symptomatology questionnaire and RAND 36 Health Survey. Once patients were >6-months from implantation, a repeat GES was obtained and patients completed a postoperative GI symptomatology questionnaire and RAND 36 Health Survey. Ten of 16 patients in this case series were >6-months from implantation. One was lost to follow-up. An F-test was used to establish equality of standard deviations between the 16 patients evaluated preoperatively and the subset of 10 patients evaluated postoperatively. A Student's t-test was used to evaluate the significance of differences in pre- and postoperative results. RESULTS: Average operating time was 117 min with no intraoperative complications. The majority of patients were discharged on postoperative day 1. There were two complications in the postoperative period. Patients experienced a significant decrease in nausea and vomiting as measured by the GI symptomatology questionnaire. Half of all patients no longer required gastric prokinetic medications and there was a subjective reduction of pyrosis, early satiety, and epigastric pain. A significant increase in quality of life as measured by the RAND 36 Health Survey was seen, and six of eight patients no longer demonstrated gastroparesis on GES. CONCLUSION: Laparoscopic implantation of an electrical stimulation device is a safe and effective treatment by subjective and objective standards for the management of medically refractory gastroparesis.
