Not Yet RecruitingPhase 4

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

200 participantsStarted 2024-10-01

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: 2 weeks postoperative

Postoperative outcomes assessment: The Postoperative Recovery Profile (PRP) Questionnaire

Timeframe: 6 weeks postoperative

Trial details

NCT IDNCT06601868

SponsorUniversitair Ziekenhuis Brussel

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

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