The Impact of Nutritional Optimization to Enhance Post-operative Outcomes Using the R-Support Supplements
- Conditions
- AbdominoplastyBreast ReductionAutologous Breast ReconstructionBody Contouring Surgery
- Interventions
- Dietary Supplement: R-Support Prepare & After nutritional supplement
- Registration Number
- NCT06601868
- Lead Sponsor
- Universitair Ziekenhuis Brussel
- Brief Summary
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.
Post-operative 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 post-operative 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.
- Detailed Description
The aim of the pilot study is to assess the potential enhanced post-operative recovery of patients receiving nutrient supplementation (intervention) before and after surgery versus patients that do not receive nutrient supplementation (control). It is a multi-centric study taking place in Belgium and in the Netherlands and the study sites include the hospitals: UZ Brussel (BE), Delta Chirec (BE) and Zuyderland Medical Center (NL).
The study is a pilot study. The end goal is a randomized controlled trial. A total of 200 patients will be included in this study. The inclusion criteria for the study are participants with ASA I or II, aged between 18 and 65, and undergoing one of the following types of surgery: abdominoplasty, breast reduction, breast reconstruction through a DIEP-flap, or extensive circumferential liposuction and body contouring surgery.
Every patient that meets the inclusion criteria and has given their informed patient consent, will be allocated to either the intervention or control group through a randomization algorithm: 100 patients without R-Support supplementation (control group) and 100 patients with R-Support supplementation (intervention group).
The duration of the study will be a total of 8 weeks, divided into a 2-week preoperative period and a 6-week postoperative period. The treatment period will be 28 days: 14 days preoperative (Supplementation of the R-Support Recover Prepare) and 14 days postoperative (Supplementation of the R-Support Recover After).
The data regarding the post-operative recovery will be based on the PRP-Questionnaire and Functional Recovery Index. The combination of these 2 questionnaires will give a general overview of the post-operative recovery, both physically and psychologically, as well as the speed of recovery in the early post-operative phase. The investigators hypothesize that the intervention group (with R-Support) will have quicker post-operative recovery than the control group (without R-Support). Moreover data regarding the length of hospital stay and early post-operative complications (minor not requiring surgery, such as wound dehiscence \<2cm and localized infection and major, requiring surgery, such as wound dehiscence \>2cm and infection requiring surgical debridement) will be collected. The investigators suppose that a body that is better prepared for surgery may, hypothetically, recover more quickly from the surgery. This may be quantified in a reduced number of hospitalized days and a reduced number of wound complications. Thus the endpoint of the study are enhanced postoperative recovery, reduced early complications (wound dehiscence, infection) and reduced hospital stay.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
-
ASAI&II
-
Age 18-65
-
Type of surgery:
- Abdominoplasty o Breast reduction
- Breast reconstruction through a DIEaP-flap
- Extensive circumferential liposuction and body contouring surgery
-
Patients with systemic illness, including:
- Diabetes
- Immune deficiencies
- Severe cardiovascular disease
- Renal insufficiency
-
Active smokers or smokers that didn't quit 4 weeks prior to surgery
-
Patients under chemotherapy (Patients currently undergoing chemotherapy are not allowed to participate in this study. Patient undergoing previous chemotherapy are allowed to participate in this study, as long as the chemotherapy ended 6 months before the planned surgery and are currently in remission or free of disease.)
-
Patients after bariatric surgery with partial or complete stomachresection
-
Patients taking SSRI medication
-
Pregnancy
-
ASAIII&IV
-
Gluten intolerance
-
Lactose intolerance
-
Allergy or hypersensitivity to fish, soya, milk, shellfish.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 100 patients with R-Support supplementation (intervention group) R-Support Prepare & After nutritional supplement The treatment period for the intervention group will last 28 days, divided into two phases: 14 days preoperative and 14 days postoperative. During the preoperative phase, participants will consume one shake per day. Each shake will consist of 35 grams (3 scoops) of R-Support Prepare mixed with 250 milliliters of water or milk. This regimen will be followed for 14 days leading up to the surgery. During the postoperative phase, participants will consume one shake per day. Each shake will consist of 35 grams (3 scoops) of R-Support After mixed with 250 milliliters of water or milk. This regimen will be followed for 14 days following the surgery.
- Primary Outcome Measures
Name Time Method 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. 2 weeks postoperative 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.Postoperative outcomes assessment: The Postoperative Recovery Profile (PRP) Questionnaire 6 weeks postoperative 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.
- Secondary Outcome Measures
Name Time Method Length of hospital stay 1 week postoperative 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.
Early postoperative complication assessment 1 and 2 weeks postoperative 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.