Clinical trial NCT06601868: The Impact of Nutritional Optimization to Enhance Postoperative Outcomes Using the R-Support Supplements
Official title: The Impact of Nutritional Optimization to Enhance Postoperative Outcomes Using the R-Support Supplements
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Abdominoplasty
Breast Reduction
Autologous Breast Reconstruction
Body Contouring Surgery
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: Chirec
name: Zuyderland Medical Centre
First posted: 2024-09-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: 2 weeks postoperative
measure: Postoperative outcomes assessment: The Postoperative Recovery Profile (PRP) Questionnaire
timeFrame: 6 weeks postoperative
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 1 week postoperative
measure: Early postoperative complication assessment
timeFrame: 1 and 2 weeks postoperative
Other outcomes:
Locations:
Study officials:
References: