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

Study acronym: R-Support
StatusUnknown
PhasePhase 4
Started
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Record status
This record was last updated September 20, 2024 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Not Yet Recruiting
  2. Secondary endpoints: details revised at 2 of 2 entries
    • Study description shortened, about 28 words
    • Study title revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06601868
Lead Sponsor Universitair Ziekenhuis Brussel
Collaborators: Chirec, Zuyderland Medical Centre
Conditions
(from sponsor)		 Abdominoplasty, Breast Reduction, Autologous Breast Reconstruction, Body Contouring Surgery
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov