AbdominoplastyPhase 4R-SupportNCT06601868
The Impact of Nutritional Optimization to Enhance Postoperative Outcomes Using the R-Support Supplements
A Phase 4 study testing R-Support Prepare & After nutritional supplement in people with Abdominoplasty and Breast Reduction, run by Universitair Ziekenhuis Brussel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominoplasty, Breast Reduction, Autologous Breast Reconstruction
- What is being tested?
- R-Support Prepare & After nutritional supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
About this study
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.
Read more
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.
Read the detailed description
The aim of this pilot study is to assess the potential for enhanced postoperative recovery in patients receiving nutrient supplementation (intervention) before and after surgery, compared to patients who do not receive nutrient supplementation (control). This is a multi-center study taking place in Belgium and the Netherlands, with study sites including the following hospitals: UZ Brussel (BE), Delta CHIREC (BE), and Zuyderland Medical Center (NL).
This is a pilot study, with the end goal being a randomized controlled trial. A total of 200 patients will be included. The inclusion criteria are participants classified as ASA I or II, aged between 18 and 65, and undergoing one of the following types of surgery: abdominoplasty, breast reduction, breast reconstruction via DIEP-flap, or extensive circumferential liposuction and body contouring surgery.
Every patient who meets the inclusion criteria and provides informed consent will be randomly allocated to either the intervention or control group via a randomization algorithm: 100 patients without R-Support supplementation (control group) and 100 patients with R-Support supplementation (intervention group).
The study will last 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 preoperatively (supplementation with R-Support Recover Prepare) and 14 days postoperatively (supplementation with R-Support Recover After).
Data regarding postoperative recovery will be assessed using the PRP-Questionnaire and the Functional Recovery Index. These two questionnaires combined will provide a comprehensive overview of postoperative recovery, both physically and psychologically, as well as the speed of recovery in the early postoperative phase. The investigators hypothesize that the intervention group (with R-Support) will experience quicker postoperative recovery than the control group (without R-Support). Additionally, data on the length of hospital stay and early postoperative complications (minor, not requiring surgery, such as wound dehiscence <2 cm and localized infection; and major, requiring surgery, such as wound dehiscence >2 cm and infection requiring surgical debridement) will be collected. The investigators suggest that a body better prepared for surgery may, hypothetically, recover more quickly. This could be reflected in fewer hospitalized days and fewer wound complications. The study's endpoints are enhanced postoperative recovery, reduced early complications (wound dehiscence, infection), and shortened hospital stays.
- Conditions
- Abdominoplasty, Breast Reduction, Autologous Breast Reconstruction, Body Contouring Surgery
- Being tested
- R-Support Prepare & After nutritional supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-Support Prepare & After nutritional supplementDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: R-Support Prepare & After nutritional supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 weeks postoperative
Secondary outcomes (2)
Length of hospital stay
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.
Measured: 1 week postoperative
Early postoperative complication assessment
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.
Measured: 1 and 2 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbdominoplastyStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Chirec, Zuyderland Medical Centre
- Responsible party
- Principal investigator, Letizia Georgiou, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601868
- Sponsor's protocol ID
- 23440_R-Support
- Acronym
- R-Support
- Status last verified
- Sep 2024
- First submitted
- 5 Aug 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared among researchers involved in the multicentric study across the hospitals of Delta Chirec, UZ Brussel, and Zuyderland Medical Center. This collaborative approach ensures that the research findings can be comprehensively analyzed and validated across multiple study sites, enhancing the overall quality and impact of the research.
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Nutritional Optimization to Enhance Postoperative Outcomes Using the R-Support Supplements
- ClinicalTrials.gov ID
- NCT06601868
- Acronym / sponsor ID
- R-Support / 23440_R-Support
- Conditions
- Abdominoplasty, Breast Reduction, Autologous Breast Reconstruction, Body Contouring Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Chirec, Zuyderland Medical Centre
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of this pilot study is to assess the potential for enhanced postoperative recovery in patients receiving nutrient supplementation (intervention) before and after surgery, compared to patients who do not receive nutrient supplementation (control). This is a multi-center study taking place in Belgium and the Netherlands, with study sites including the following hospitals: UZ Brussel (BE), Delta CHIREC (BE), and Zuyderland Medical Center (NL).
This is a pilot study, with the end goal being a randomized controlled trial. A total of 200 patients will be included. The inclusion criteria are participants classified as ASA I or II, aged between 18 and 65, and undergoing one of the following types of surgery: abdominoplasty, breast reduction, breast reconstruction via DIEP-flap, or extensive circumferential liposuction and body contouring surgery.
Every patient who meets the inclusion criteria and provides informed consent will be randomly allocated to either the intervention or control group via a randomization algorithm: 100 patients without R-Support supplementation (control group) and 100 patients with R-Support supplementation (intervention group).
The study will last 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 preoperatively (supplementation with R-Support Recover Prepare) and 14 days postoperatively (supplementation with R-Support Recover After).
Data regarding postoperative recovery will be assessed using the PRP-Questionnaire and the Functional Recovery Index. These two questionnaires combined will provide a comprehensive overview of postoperative recovery, both physically and psychologically, as well as the speed of recovery in the early postoperative phase. The investigators hypothesize that the intervention group (with R-Support) will experience quicker postoperative recovery than the control group (without R-Support). Additionally, data on the length of hospital stay and early postoperative complications (minor, not requiring surgery, such as wound dehiscence <2 cm and localized infection; and major, requiring surgery, such as wound dehiscence >2 cm and infection requiring surgical debridement) will be collected. The investigators suggest that a body better prepared for surgery may, hypothetically, recover more quickly. This could be reflected in fewer hospitalized days and fewer wound complications. The study's endpoints are enhanced postoperative recovery, reduced early complications (wound dehiscence, infection), and shortened hospital stays.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Dietary Supplement: R-Support Prepare & After nutritional supplementThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ASAI\&II
- Age 18-65
- Type of surgery:
Key exclusion criteria (14 listed)
- Patients with systemic illness, including:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R-Support Prepare & After nutritional supplementR-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. | Dietary supplement | 100 patients with R-Support supplementation (intervention group) |
Primary outcome
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.
Time frame: 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
Time frame: 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.
2 secondary outcomes
Length of hospital stay
Time frame: 1 week postoperative
Early postoperative complication assessment
Time frame: 1 and 2 weeks postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: Undecided. Data will be shared among researchers involved in the multicentric study across the hospitals of Delta Chirec, UZ Brussel, and Zuyderland Medical Center. This collaborative approach ensures that the research findings can be comprehensively analyzed and validated across multiple study sites, enhancing the overall quality and impact of the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing R-Support Prepare & After nutritional supplement in people with Abdominoplasty and Breast Reduction, run by Universitair Ziekenhuis Brussel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 2 weeks postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.