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

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

Interventions

DIETARY_SUPPLEMENT

R-Support Prepare & After nutritional 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.

Sponsors & Collaborators

• Chirec

  collaborator OTHER

• Zuyderland Medical Centre

  collaborator OTHER

• Universitair Ziekenhuis Brussel

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-10-01

Primary Completion

2025-12-31

Completion

2025-12-31