Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06601868
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
The Impact of Nutritional Optimization to Enhance Postoperative Outcomes Using the R-Support Supplements
Sponsor:
None
Organization:
None
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:
No
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 studys 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 studys endpoints are enhanced postoperative recovery reduced early complications wound dehiscence infection and shortened hospital stays
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None