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.
Scintigraphically proven gastroparesis
Failed conservative therapy
Severe impairment of quality of life
Written informed consent
Age < 18 years
Prior gastric resection
The study includes patients with (1) scintigraphically proven gastroparesis, (2) failed conservative therapy, (3) who undergo laparoscopic gastric pacemaker implantation.
Cohort
Prospective
Gastric pacemaker (Enterra system) implantation
DeviceLaparascopic implantation of a gastric pacemaker (Enterra system) for patients with therapy refractive gastroparesis
Symptoms
Symptom severity/Improvement of symptoms pre-/post gastric pacemaker implantation using the standardized Gastroparesis Cardinal Symptom Index (GCSI). The GCSI is based on three subscales: post-prandial fullness/early satiety (4 items); nausea/vomiting (3 items), and bloating (2 items). A total score of 45 can be achieved. A high score indicates more severe symptoms.
Health-related quality of life
Health-related quality of life pre-/post gastric pacemaker implantation using the GIQLI questionnaire (Gastrointestinal Quality of Life Index). GIQLI is a validated instrument to assess HRQoL among patients with gastrointestinal disorders. The questionnaire consists of 36 questions and is subdivided into five subcategories (symptoms, emotion, physical function, social function, and medical treatment). Total scores between 0 and 144 can be achieved. Respective total scores for the specific subcategories are symptoms=76, emotions=20, physical=28, and social=20. Higher scores represent a higher HRQoL.17
Hospital admission
Frequency of hospital admission for further treatment pre/post gastric pacemaker implantation
Perioperative complication rate
Perioperative complications such as wound infection, pain, dysfunctional device
Click on the lead sponsor to view all of their trials.
Evangelic Hospital Kalk Cologne
Lead sponsor
University of Cologne
Sponsor institution
Enterra Medical, Inc.
Collaborator
