Gastroparesis Outcome Longitudinal Database Enrolled Numerically
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/22/2019 |
| Start Date: | January 1, 2013 |
| End Date: | January 1, 2023 |
| Contact: | Thomas Abell, MD |
| Email: | thomas.abell@louisville.edu |
| Phone: | (502)852-6991 |
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.
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.
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
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
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
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