Gastroparesis Outcome Longitudinal Database Enrolled Numerically
University of Louisville
Summary
GOLDEN is a longitudinal database of patients with the symptoms (Sx) of gastroparesis (Gp) who were seen and recorded at the University of Louisville from 2012 and is ongoing. Patients are enrolled and followed by sequential numbers and may include legacy patients seen at other centers by some of the same team and who are reported as part of the series. Outcome relate to patients Sx, survival, quality of life and other measures as detailed below, over time. The study tracks patients regardless of treatment but specifically focuses on GI Neuromodulation (gastric electrical stimulation - GES), Immunotherapy (IVIG), and Pyloric therapies (pyloroplasty, endoscopic). If treatments were administered GOLDEN allows for examination and stratification of outcome by groups both at baseline and at follow up.
Description
1. All patients seen with the Sx of Gp and who were evaluated for diagnosis and/or treatment 2. Including legacy patients who were seen and treated at previous locations (Mississippi, Arkansas, Tennessee) before Kentucky if they were part of a clinical research series. 3. Numbers of patients referred or consulted for Gp Sx who were Drug Refractory. 4. Interventions: GI Neuromodulation with gastric electrical stimulation (GES); Immunotherapy with Intravenous Immunoglobulin; Pyloric therapies such as pyloroplasty, surgical or endoscopic. 5. Data for evaluation by: Sx assessments by whatever scal…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Inclusion: * Patients with the symptoms (Sx) of drug refractory gastroparesis * Disordered nutrition by standardized assessment * Ability to assess current symptom status * Ability to measure other medical conditions Exclusion: * Anatomic obstruction of the GI Tract * Pregnancy * Inability of patient or guardian to sign informed consent, if needed * Psychiatric disorders precluding assessment and treatment of the patient's GI condition
Interventions
- DeviceGI Neuromodulation
The investigators would include follow up with: No treatment; temp GES only; temp followed by Perm GES; Other device therapies; specific pain therapies; drug therapies, including investigational drugs; immunotherapy; pyloric therapies; psychological/behavioral therapies; nutritional support; radiological and surgical therapies; infection rates related to procedures; if enrolled in any therapy research trials; morbidity and mortality after specific therapies; other treatments used.
- DrugImmunotherapy
The investigators would include follow up with: No treatment; temp gastric electrical stimulation (GES) only; temp followed by Perm GES; Other device therapies; specific pain therapies; drug therapies, including investigational drugs; immunotherapy; pyloric therapies; psychological/behavioral therapies; nutritional support; radiological and surgical therapies; infection rates related to procedures; if enrolled in any therapy research trials; morbidity and mortality after specific therapies; other treatments used.
- ProcedurePyloric Therapies
The investigators would include follow up with: No treatment; temp gastric electrical stimulation (GES) only; temp followed by Perm GES; Other device therapies; specific pain therapies; drug therapies, including investigational drugs; immunotherapy; pyloric therapies; psychological/behavioral therapies; nutritional support; radiological and surgical therapies; infection rates related to procedures; if enrolled in any therapy research trials; morbidity and mortality after specific therapies; other treatments used.
Location
- University of LouisvilleLouisville, Kentucky