The Impact of Preoperative FoodforCare at Home

Surgery Clinical Trial

Official title:

The Impact of Preoperative FoodforCare at Home on Nutritional and Functional Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03488511
• Other study ID #: 2016-3043
• Status: Completed
• Phase: N/A
• Start date: March 5, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: April 2019
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Surgery

Intervention

Other:
• FoodforCare at home
Six small protein rich meals that will be delivered twice a week for 3 weeks.

Locations

Country	Name	City	State
Netherlands	Maasziekenhuis Pantein	Beugen	Noord-Brabant
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

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