The Impact of Nutritional Optimization to Enhance Postoperative Outcomes Using the R-Support Supplements
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversitair Ziekenhuis Brussel
About this trial
The aim of this pilot study is to evaluate the potential benefits of nutrient supplementation on post-operative recovery for patients undergoing certain types of surgery, compared to those who do not receive such supplementation. The multi-center study will be conducted in Belgium and the Netherlands at UZ Brussel, Delta CHIREC, and Zuyderland Medical Center.
The pilot study will serve as a precursor to a randomized controlled trial and will include 200 patients. Participants must be classified as ASA I or II, aged between 18 and 65, and undergoing abdominoplasty, breast reduction, breast reconstruction through a DIEP-flap, or extensive circumferential liposuction and body contouring surgery.
Eligible patients who provide informed consent will be randomly assigned to either the intervention group, receiving R-Support supplementation, or the control group, without supplementation. Each group will consist of 100 patients. The study will span 8 weeks, with a 2-week preoperative period and a 6-week postoperative period. The treatment will involve a 28-day supplementation period, with R-Support Recover Prepare given 14 days preoperatively and R-Support Recover After given 14 days postoperatively.
Postoperative recovery will be assessed using the PRP-Questionnaire and Functional Recovery Index, which together will measure physical and psychological recovery, as well as the speed of recovery in the early postoperative phase. The study hypothesizes that the intervention group will experience quicker recovery than the control group. Additionally, data on hospital stay duration and early postoperative complications will be collected, with the expectation that better-prepared bodies will recover faster, potentially leading to fewer hospitalized days and complications. The study aims to demonstrate enhanced postoperative recovery, reduced early complications (such as wound dehiscence and infection), and shorter hospital stays.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
ASAI&II
Age 18-65
Abdominoplasty o Breast reduction
Breast reconstruction through a DIEaP-flap
Disqualifiers
Diabetes
Immune deficiencies
Severe cardiovascular disease
Renal insufficiency
Trial design
Design model
Parallel
Treatments tested in this trial
R-Support Prepare & After nutritional supplement
Dietary supplementR-Support is a nutritional supplement containing proteins, Vitamine A, Vitamine B6, Vitamine B11, Vitamine B12, Vitamine C, Vitamine D3, Vitamine E, IJzer, Koper, Selenium, Zink, Magnesium, Omega-3 and Beta-glucanen.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: 100 patients without R-Support supplementation (control group)No intervention 0 interventions
Group B: 100 patients with R-Support supplementation (intervention group)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Postoperative outcomes assessment: The Functional Recovery Index Questionnaire evaluates pain, social, lower limb, and physical activity, and the Postoperative Recovery Profile assesses physical, psychological, and social factors.
The Functional Recovery Index (FRI) focuses on pain and social activity, with a particular emphasis on lower limb mobility, which is often compromised after surgery. This tool aims to assess whether R-Support supplementation improves mobility and overall recovery. Recovery will be quantified using a scale from 0 to 10, where 0 indicates no difficulty at all, and 10 represents extreme difficulty.
Time frame
2 weeks postoperative2
Postoperative outcomes assessment: The Postoperative Recovery Profile (PRP) Questionnaire
The Postoperative Recovery Profile (PRP) Questionnaire assesses physical symptoms, functions, psychological aspects, social interactions, and activity levels. Patients will complete both questionnaires independently. Recovery will be quantified using a scale from 0 to 10, where 0 indicates no difficulty at all, and 10 represents extreme difficulty. It is hypothesized that patients receiving R-Support will experience a quicker recovery compared to those who do not.
Time frame
6 weeks postoperativeSecondary outcomes
1
Length of hospital stay
The postoperative complication assessment will focus on the length of hospital stay, measured in days. This measurement aims to determine whether patients receiving R-Support have a shorter hospital stay compared to those who do not. A reduced length of stay may indicate quicker recovery, highlighting the potential benefits of R-Support supplementation in enhancing postoperative outcomes.
Time frame
1 week postoperative2
Early postoperative complication assessment
The early postoperative complication assessment will classify complications into two categories: minor and major. Minor complications include issues such as wound dehiscence less than 2 cm and localized infections that do not require extensive intervention. Major complications involve more severe cases, such as wound dehiscence greater than 2 cm and infections requiring surgical debridement. These secondary objectives are intended to assess the effect of preoperative nutritional optimization on postoperative recovery. The hypothesis is that improved nutritional status before surgery may result in fewer wound complications.
Time frame
1 and 2 weeks postoperativeLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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