Gastric Per-Oral Endoscopic Myotomy (G-POEM) for the Treatment of Gastroparesis
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Mohammad Al-Haddad, MD · PRINCIPAL_INVESTIGATOR · Indiana University
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What this trial measures
- Assessment of Change in Gastroparesis Cardinal Symptom Index (GCSI) from baseline to post G-POEM60 months span: baseline and assess change at 1 month, 3 month, 6 month, 12 month, 24 month, 36 month, 48 month & 60 months
The Gastroparesis Cardinal Symptom Index (GCSI) is used for assessing severity of symptoms associated with gastroparesis. Patients are to score each of the 9 symptom criteria on 0 (None) to 5 (Very Severe) Likert Scale. The higher the score the more symptomatic from gastroparesis the patient is. Nausea or Vomiting (score 0-5 for each of the following 3 criteria) * Nausea * Retching * Vomiting Postprandial fullness or early satiety (score 0-5 for each of the following 4 criteria) * Stomach Fullness * Not able to finish a normal-sized meal * Feeling excessively full after meals * Loss of appetite Bloating (score 0-5 for each of the following 2 criteria) * Bloating * Stomach visibly larger
- Assessment of Change in Patient Assessment of gastrointestinal disorders-symptom severity index (PAGI-SYM) score from baseline to post G-POEM60 months span: baseline and assess change at 1,3,6,12,24, 36,48 & 60 months
Change in PAGI-Sym score: The PAGI-SYM is composed of 20 items and 6 subscales: heartburn/regurgitation (7 items), nausea/vomiting (3 items), postprandial fullness/early satiety (4 items), bloating (2 items), upper abdominal pain (2 items), and lower abdominal pain (2 items). Subscale scores are calculated by averaging across items comprising the subscale; scores vary from 0 (none or absent) to 5 (very severe)
- Assessment of Change in G-POEM SF-36 Health Survey score from baseline to post G-POEMbaseline and assess change at 1,3,6,12,24,36,48 & 60 months
Change in health belief questionnaire (SF-36) score: Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability and the higher scores indicate better health
- Assessment of change in Gastric Emptying Scan (GES) (solid phase, 4 hour study) from baseline to post G-POEMbaseline; and assess change at 6, and 24 months
we will track change in GES at 6 months and 24 months post G-POEM and compare to baseline. Normal GES should have under 5% at 4 hours