Laparoscopic Implantation of a Gastric Pacemaker in the Treatment of Gastroparesis
Laparoscopic Implantation of a Gastric Pacemaker is a Low-complication Alternative for Gastroparesis
Evangelic Hospital Kalk Cologne
50 participants
Jan 1, 2023
OBSERVATIONAL
Conditions
Summary
Gastroparesis is a burdensome condition that is caused by abnormal motor function of the stomach that results in delayed gastric emptying. It typically manifests with bloating, nausea, vomiting, abdominal pain, and even excessive weight loss and dehydration. The most common causes of gastroparesis are idiopathic, diabetic, medication-induced or iatrogenic (postsurgical) gastroparesis. Implantation of a gastric neurostimulation device is a surgical option to improve gastric emptying in patients with medication-refractory gastroparesis. Enterra® system is a gastric electrical stimulation that sends mild pulses through leads implanted in the stomach wall that stimulate gastric smooth muscles and nerves in order to improve symptoms and quality of life. Aim of the investogators' registry trial is to evaluate the feasibility and efficacy of laparoscopic gastric pacemaker implantation for electrical stimulation (Enterra® system). Primary endpoints of the study are symptom severity, health-related quality of life, and frequency of hospitalization before and after pacemaker implantation, perioperative complication rate, and cost effectiveness.
Eligibility
Inclusion Criteria5
- Scintigraphically proven gastroparesis
- Failed conservative therapy
- Severe impairment of quality of life
- Written informed consent
- German language
Exclusion Criteria2
- Age < 18 years
- Prior gastric resection
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Interventions
Laparascopic implantation of a gastric pacemaker (Enterra system) for patients with therapy refractive gastroparesis
Locations(1)
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NCT06661668