Surgery Clinical Trial
Official title:
The Impact of Preoperative FoodforCare at Home on Nutritional and Functional Outcomes
Verified date | April 2019 |
Source | Radboud University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Preoperative nutritional state is closely related to perioperative morbidity and complications. This study aims to determine the effect of a protein-rich meal service in the preoperative setting compared to usual care.
Status | Completed |
Enrollment | 126 |
Est. completion date | September 1, 2019 |
Est. primary completion date | June 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: - 18 years or older - surgical patients - living within a 40 km radius around Nijmegen/Veghel - inclusion at least 4 weeks before surgery - surgery: Urology, Orthopedics, Gynaecology, General Surgery - oral intake Exclusion criteria: - renal insufficiency (MDRD-GFR (glomerular filtration rate) < 60ml/min and/or proteinuria)* - food allergy - planned vacation during intervention period - proteinuria is defined in case of a protein creatinine ratio > 0.5g/10mmol or an albuminuria > 300mg/day. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maasziekenhuis Pantein | Beugen | Noord-Brabant |
Netherlands | Radboudumc | Nijmegen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Radboud University |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Protein intake relative to requirements | 3-day food diary filled in at baseline and after 3 weeks. | 3 weeks | |
Secondary | Nutritional status | Patient Generated Subjective Global Assessment (PG-SGA) performed at baseline and after 3 weeks. | 3 weeks | |
Secondary | Quality of life and overall health status | ShortForm-36 questionnaire filled in at baseline and after 3 weeks. This questionnaire consists of 36 questions about physical and psychological aspects. Each item is scored on a 0 to 100 range. The higher the score, the higher the quality of life of the patient. | 3 weeks | |
Secondary | Patient satisfaction | Questionnaire filled in after 3 weeks of receiving meals. This is a self-developed questionnaire which does not have a total score. Each question will be analyzed separately. Questions consist of grading from 0-10 (the higher, the better the outcome) or with a 5-point Likert scale (completely disagree-completely agree). | 3 weeks | |
Secondary | Length of stay | These are determined retrospectively in the electronic patient file EPIC 2 months after baseline | 2 months | |
Secondary | Readmissions | These are determined retrospectively in the electronic patient file EPIC 2 months after baseline | 2 months | |
Secondary | Postoperative complications | This is reported using a standardized classification system 2 months after baseline | 2 months | |
Secondary | Energy intake relative to requirements | 3-day food diary filled in at baseline and after 3 weeks. | 3 weeks | |
Secondary | Functional status | Short Physical Performance Battery (SPPB) performed at baseline and after 3 weeks. | 3 weeks | |
Secondary | Muscle strength | Hand grip strength (kg) performed at baseline and at 3 weeks. | 3 weeks |
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