Clinical trial NCT03488511: The Impact of Preoperative FoodforCare at Home
Official title: The Impact of Preoperative FoodforCare at Home on Nutritional and Functional Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Protein intake relative to requirements
timeFrame: 3 weeks
Secondary outcomes:
measure: Nutritional status
timeFrame: 3 weeks
measure: Quality of life and overall health status
timeFrame: 3 weeks
measure: Patient satisfaction
timeFrame: 3 weeks
measure: Length of stay
timeFrame: 2 months
measure: Readmissions
timeFrame: 2 months
measure: Postoperative complications
timeFrame: 2 months
measure: Energy intake relative to requirements
timeFrame: 3 weeks
measure: Functional status
timeFrame: 3 weeks
measure: Muscle strength
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
city: Beugen
country: Netherlands
facility: Maasziekenhuis Pantein
state: Noord-Brabant
Study officials:
affiliation: Radboud University Medical Center
name: Manon van den Berg, PhD
role: STUDY_CHAIR
References: