Clinical trial NCT03876288: Gastroparesis Outcome Longitudinal Database Enrolled Numerically
Official title: Gastroparesis Outcome Longitudinal Database Enrolled Numerically
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastroparesis
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients seen

Brief 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, regardless of whether any treatment was given or not. If treatments were administered GOLDEN allows for examination and stratification of outcome by groups both at baseline and at follow up.

Detailed 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 scales used; Measures of health related quality of life; Psychological and pain assessments; Gastric emptying texts; Electrical measures; Autonomic measure; Serologic measures; Full thickness biopsies; Measures of outpatient \& Emergency Room Visits; Measures of hospitalization; Placement of endoscopic or surgical tubes; Radiological and Surgical procedures; Nutritional assessments; If enrolled in any research protocols for data; Stool biome measures; Metabolic measures; Other morbidity measures; Mortality

Eligibility criteria: 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

Primary outcomes:
measure: Patient Reported Outcome GI Symptoms
timeFrame: Change from baseline to one week to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Thomas Abell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shine A, Mathur P, Ahmed S, Ramos S, McElmurray L, Stocker A, Pinkston C, Abell TL. Low-Resolution Electrogastrogram at Baseline and Response to Temporary Gastric Electrical Stimulation-A Comparison of Cutaneous With Mucosal Recordings. Neuromodulation. 2022 Dec;25(8):1150-1159. doi: 10.1016/j.neurom.2021.12.008. Epub 2022 Feb 17.