Surgery
Conditions
Brief summary
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.
Detailed description
Each year, approximately 1.4 million patients in the Netherlands are operated. Adequate nutritional intake, mainly protein intake, before surgery is important to improve preoperative muscle strength and functional capacity. However, up to 40% of patients admitted to the hospital suffer from malnutrition and this further deepened during hospitalization, which is an independent risk factor for peri-operative morbidity and severe complications, ranging from increased muscle loss, to higher infection rates, delayed wound healing and subsequently a prolonged hospital stay. An adequate food service is one strategy to improve protein intake and thereby the nutritional status. Extension of the study period to the out-of-hospital setting is recommended to explore the effects of long-term exposure to this concept on nutritional, functional and clinical outcomes. Therefore, the investigators aim to evaluate whether home delivered protein-rich meals, as part of FoodforCare meal service, in the preoperative setting improves protein intake in patients undergoing surgery, compared to usual care. The second aim is to investigate the effects on functional and clinical outcomes.
Interventions
OTHERFoodforCare at home
Six small protein rich meals that will be delivered twice a week for 3 weeks.
Sponsors
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Protein intake relative to requirements | 3 weeks | 3-day food diary filled in at baseline and after 3 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life and overall health status | 3 weeks | 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. |
| Patient satisfaction | 3 weeks | 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). |
| Length of stay | 2 months | These are determined retrospectively in the electronic patient file EPIC 2 months after baseline |
| Readmissions | 2 months | These are determined retrospectively in the electronic patient file EPIC 2 months after baseline |
| Nutritional status | 3 weeks | Patient Generated Subjective Global Assessment (PG-SGA) performed at baseline and after 3 weeks. |
| Energy intake relative to requirements | 3 weeks | 3-day food diary filled in at baseline and after 3 weeks. |
| Functional status | 3 weeks | Short Physical Performance Battery (SPPB) performed at baseline and after 3 weeks. |
| Muscle strength | 3 weeks | Hand grip strength (kg) performed at baseline and at 3 weeks. |
| Postoperative complications | 2 months | This is reported using a standardized classification system 2 months after baseline |
Countries
Netherlands
Outcome results
None listed