The Impact of Nutritional Optimization to Enhance Postoperative Outcomes Using the R-Support Supplements

NCT06601868 | Not Yet Recruiting Phase 4

• 1 other identifier: 23440_R-Support
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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. 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.

Conditions

Abdominoplasty; Breast Reduction; Autologous Breast Reconstruction; Body Contouring Surgery

Outcome Measures

Primary Outcomes (2)

• 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.

  2 weeks postoperative

• 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.

  6 weeks postoperative

Secondary Outcomes (2)

• Length of hospital stay

  1 week postoperative

• Early postoperative complication assessment

  1 and 2 weeks postoperative

Study Arms (2)

100 patients without R-Support supplementation (control group)

NO INTERVENTION

These patients will have no intervention, will not take the nutritional supplements

100 patients with R-Support supplementation (intervention group)

ACTIVE COMPARATOR

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.

Dietary Supplement: R-Support Prepare & After nutritional supplement

Interventions

R-Support Prepare & After nutritional supplement DIETARY_SUPPLEMENT

R-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.

100 patients with R-Support supplementation (intervention group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Chirec: collaborator
• Zuyderland Medical Centre: collaborator

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow in Plastic Surgery

Model Details: This pilot study will include a total of 200 patients. Participants will be randomly assigned to one of two groups using a randomization algorithm. The study will be non-blinded, meaning both participants and researchers will be aware of group assignments.

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 20, 2024

Record last verified: 2024-09