Laparoscopic Surgery to Implant a Gastric Pacemaker Enterra System for Treating Gastroparesis

What this Trial Is About

Gastroparesis is a challenging condition caused by abnormal stomach movement that delays gastric emptying, leading to symptoms like bloating, nausea, vomiting, abdominal pain, weight loss, and dehydration. It can result from idiopathic, diabetic, medication-induced, or postsurgical causes. Researchers are evaluating the feasibility and effectiveness of using a gastric neurostimulation device called the Enterra system, which delivers mild electrical pulses to stimulate stomach muscles and nerves, aiming to improve symptoms and quality of life in patients with gastroparesis who do not respond to medication. The study involves patients with confirmed gastroparesis who have not improved with conservative treatments. These patients undergo laparoscopic implantation of the Enterra gastric pacemaker, a device implanted in the stomach wall to provide electrical stimulation. This observational registry trial assesses the impact of this surgical treatment over several years, focusing on symptom severity, quality of life, hospitalization frequency, perioperative complications, and cost-effectiveness. Participants will be monitored for up to five years, with evaluations of symptoms and health-related quality of life using specific questionnaires. Researchers will also track hospital admissions and possible surgical complications within one year. Assessments include gastric emptying studies to confirm diagnosis, ongoing symptom and quality of life measurement, and monitoring of safety and effectiveness of the implanted device. The total participation duration varies with long-term follow-up to observe lasting outcomes.

Laparoscopic Implantation of a Gastric Pacemaker in the Treatment of Gastroparesis