K31.3 K31.8 G99.0
Conditions
Interventions
Group 1: pre-interventional: upper GI-Endoscopy, objective gastric emptying study (C13-Breath-test, Gastric scintigraphy), if available Endo-Flip
EQ-5L-5D
Trial begin: gastric peroral endoscopic myotomy
post-interventional 3-6 month: GCSI-Score, objective gastric emptying study (C13-Breath-test, Gastric scintigraphy), if available Endo-Flip
EQ-5L-5D
post-interventional 12 month: objective gastric emptying study (C13-Breath-test, Gastric scintigraphy), if available Endo-Flip
post-interventional 24 month: objective gastric emptying study (C13-Breath-test, Gastric scintigraphy), if available Endo-Flip
EQ-5L-5D
Sponsors
Universitätsklinikum Augsburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: patients with gastroparesis, which is diagnosed with an objective gastric emptying study (C13-breath test, gastric emptying scintigraphy) and GCSI-Score over 0 patient will or have received a G-POEM procedure
Exclusion criteria
Exclusion criteria: Patient denies follow-up Patient with gastroparesis without symptoms (GCSI Score = 0) Gastric emptying delay due to other circumstances excluding gastroparesis disease Patient unable to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical success- reduction of GSCI-Score about 1 point of total score or reduction of at least 25% of two subscales after 3-6, 12 and 24 month. | — |
Secondary
| Measure | Time frame |
|---|---|
| absolute and relativ reduction of gastric emptying delay measured with an objective gastric emptying study adverse events frequency technical succress Change of life quality (EQ-5L-SD) | — |
Countries
Austria, Germany, Switzerland
Contacts
Public ContactAlanna Ebigbo
Universitätsklinikum Augsburg
Outcome results
None listed