Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2026-01-20 @ 7:32 AM
Study NCT ID:
NCT06601868
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-20
First Post:
2024-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Nutritional Optimization to Enhance Postoperative Outcomes Using the R-Support Supplements
Sponsor:
Universitair Ziekenhuis Brussel
Organization:
Study Overview
Official Title:
The Impact of Nutritional Optimization to Enhance Postoperative Outcomes Using the R-Support Supplements
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
R-Support
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: