on-invasive detection of electrical signals from the stomach after major pancreas surgery
Not Applicable
- Conditions
- Delayed gastric emptying in patients who undergo pancreaticoduodenectomyDigestive System
- Registration Number
- ISRCTN33085217
- Lead Sponsor
- ewcastle upon Tyne Hospitals NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Patients undergoing pancreaticoduodenectomy for malignant or benign disease of the pancreas, distal bile duct or duodenum
Exclusion Criteria
1. Under 18 years of age
2. Previous gastric surgery
3. Post-operative complications requiring surgical intervention
4. Major wound sepsis or rash
5. History of skin allergies or extreme sensitivity to cosmetics or lotions
6. Pregnant women
7. Vulnerable groups e.g. cognitive impairment or inability to give consent
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wave spectral (frequency and amplitude), spatial (wave directional vector) and stability (rhythm index) parameters measured using gastric Alimetry at the following timepoints: pre-operatively, day 4 postoperatively, at discharge and 6 months postoperatively.
- Secondary Outcome Measures
Name Time Method 1. Quality of life measured using the Patient Assessment of upper GastroIntestinal disorders-Quality of Life (PAGI QoL) questionnaire at 6 months<br>2. Patient satisfaction measured using a bespoke questionnaire designed by the researchers at 6 months<br>