Gastroparesis Outcome Longitudinal Database Enrolled Numerically
University of Louisville
3,000 participants
Jan 1, 2013
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria4
- 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
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Interventions
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.
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.
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.
Locations(1)
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NCT03876288