Body surface gastric mapping in paraoesophageal hernia patients Digestive System
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age over 18 years old 2. Elective para-oesophageal hernia repair (type of operation not specified) 3. Giant para-oesophageal hernia (defined by herniation of more than 50% of the stomach into the chest)
Exclusion criteria
Exclusion criteria: 1. BMI greater than 35 2. Unable to provide informed consent 3. Had previous para-oesophageal hernia repair or oesophago-gastric surgery 4. Diagnosis of an oesophago-gastric cancer 5. Emergency para-oesophageal hernia at presentation/surgery 6. Skin allergy or extreme sensitivity to cosmetics or lotions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ease and use of body surface gastric mapping device measured using patient self-reported questionnaires at any point pre-operatively and repeated 3 to 6 months post-operatively | — |
Secondary
| Measure | Time frame |
|---|---|
| Captured electrical activity data measured using data from the device correlated with patient-reported outcomes measured using a Patient Reported Outcome Score Test (POST) and the Gastroesophageal Reflux Disease-Health Related Quality of Life (GORD-HRQL) questionnaires at any point pre-operatively and repeated 3 to 6 months post-operatively. | — |
Countries
England, United Kingdom