The Role of Arginine in Oral Nutritional Supplementation in Preventing or Reducing Complications Following Colorectal Surgery in Patients Who Are Malnourished or at Risk of Malnutrition: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Presence of Postoperative Complications
研究概览
简要总结
The goal of this randomized controlled trial is to evaluate the role of a high-calorie, high-protein oral nutritional supplement enriched with arginine in the prevention or reduction of post-surgical complications in adult patients undergoing scheduled colorectal surgery who are malnourished or at risk of malnutrition.
The main questions it aims to answer are:
- Does the administration of an arginine-enriched enteral formula decrease the occurrence of post-surgical complications compared to a standard high-protein, high-calorie formula?
- Does the use of an arginine-enriched formula reduce the length of hospital stay and associated healthcare costs?
Researchers will compare a high-protein, high-calorie oral nutritional supplement (ONS) enriched with arginine, omega-3, and nucleotides (Atémpero®) to a standard high-protein, high-calorie ONS without arginine (Diaba plus®) to see if the arginine-enriched formula significantly reduces postoperative complications, such as surgical site infections and dehiscence, as well as the duration of hospital stay.
Participants will:
- Undergo a comprehensive nutritional and clinical assessment, including body composition analysis via bioelectrical impedance and handgrip strength tests.
- Receive individualized oral nutritional supplementation (either the arginine-enriched formula or the standard formula) as part of their preoperative preparation.
- Participate in five follow-up visits (baseline, 24 hours pre-surgery, 24 hours post-surgery, 5 days post-surgery, and 30 days post-surgery) for anthropometric, biochemical, and clinical monitoring.
详细描述
Overview This randomized controlled trial (RCT) aims to investigate whether a specific nutritional strategy can improve recovery for adults undergoing scheduled colorectal surgery. Specifically, the study focuses on patients who are malnourished or at risk of malnutrition, a condition affecting 45% to 60% of individuals with colorectal cancer. Malnutrition is a significant concern in surgical settings because it often leads to increased postoperative complications, such as impaired wound healing and higher rates of infection, which ultimately result in longer hospital stays and increased healthcare costs.
Background Maintaining an optimal nutritional status is a critical component of modern surgical protocols, including Enhanced Recovery After Surgery (ERAS). While standard high-protein, high-calorie supplements are frequently used, there is ongoing debate within the medical community regarding the added benefits of "immunonutrients"-specialized ingredients like arginine. Arginine is an amino acid that plays a vital role in collagen synthesis and immune system activation, both of which are essential for proper healing and the prevention of infections. This study seeks to determine if adding arginine to a standard nutritional regimen provides superior outcomes compared to standard supplementation alone.
Methodology
To ensure rigorous results, participants are divided into three distinct groups:
- Control Group: Patients who are well-nourished and do not require specialized supplementation.
- Standard Intervention Group: Malnourished patients receiving a standard high-protein, high-calorie oral nutritional supplement (ONS).
- Arginine-Enriched Group: Malnourished patients receiving a high-protein, high-calorie ONS enriched with arginine, omega-3 fatty acids, and nucleotides.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or over.
- •Patients due to undergo colorectal surgery.
- •Patients who are malnourished or at risk of malnutrition prior to surgery.
排除标准
- •Limitations on oral intake (medical conditions, health status, etc.) or contraindications to oral administration.
- •Digestive intolerance or allergy to any of the product's components.
- •Emergency colorectal surgery.
结局指标
主要结局
Presence of Postoperative Complications
时间窗: At 24 hours after the procedure and 30 days after surgery.
This dependent variable tracks whether a patient experiences any medical or surgical complications following colorectal surgery. It is recorded as a binary outcome (Yes/No) and serves as the main indicator of the intervention's success in improving patient recovery.
Surgical Site Infection
时间窗: From the date of surgery to 30 or 90 days postoperatively, depending on the procedure.
An infection occurring at the site of the surgical incision or in the surrounding tissues within the first 30 to 90 days after the procedure. It is assessed using standardized clinical criteria and recorded as Yes or No.
Postoperative Intestinal Ileus
时间窗: At 24 hours after the procedure and 30 days after surgery.
A temporary failure of the intestines to resume normal muscle contractions (peristalsis) after surgery, which prevents the passage of food and waste. It is recorded as Yes or No based on clinical observation.
Intra-abdominal Collection (Abscess)
时间窗: At 24 hours after the procedure and 30 days after surgery.
A localized accumulation of pus within the abdominal cavity. It is confirmed by the presence of bacteria in a clinical smear or by positive growth in a bacterial culture. Dichotomous qualitative variable: Yes / No.
Intestinal Ischemia
时间窗: At 24 hours after the procedure and 30 days after surgery.
A serious condition occurring when blood flow to the intestines is reduced due to a blockage in a blood vessel, typically an artery, which can lead to tissue damage or death. Dichotomous qualitative variable: Yes / No.
Intestinal Evisceration
时间窗: At 24 hours after the procedure and 30 days after surgery.
The protrusion of internal abdominal organs (such as the intestines) through a surgical wound that has reopened across all layers of the abdominal wall following a laparotomy. Dichotomous qualitative variable: Yes / No.
Bacteremia
时间窗: At 24 hours after the procedure and 30 days after surgery.
The clinical presence of viable bacteria in the patient's bloodstream, typically identified through blood cultures. Dichotomous qualitative variable: Yes / No.
Suture Dehiscence
时间窗: At 24 hours after the procedure and 30 days after surgery.
The failure or reopening of a surgical wound or an internal connection (anastomosis) where tissues were joined by sutures, allowing the edges to separate. Dichotomous qualitative variable: Yes / No.
Phlebitis
时间窗: At 24 hours after the procedure and 30 days after surgery.
Inflammation of the walls of a vein, which can occur as a complication of intravenous therapy or the surgical process. Dichotomous qualitative variable: Yes / No.
Urinary Tract Infection
时间窗: At 24 hours after the procedure and 30 days after surgery.
An infection occurring in the urinary system (urethra, bladder, or kidneys), common in surgical settings when bacteria enter the urinary tract. Dichotomous qualitative variable: Yes / No.
Pneumonia
时间窗: At 24 hours after the procedure and 30 days after surgery.
An infection that inflames the air sacs in one or both lungs, which may fill with fluid or pus, often caused by bacterial or viral infection during the recovery period. Dichotomous qualitative variable: Yes / No.
Atelectasis
时间窗: At 24 hours after the procedure and 30 days after surgery.
A complete or partial collapse of the lung or a section of the lung, which occurs when the small air sacs (alveoli) become deflated, frequently due to increased intra-abdominal pressure during surgery. Dichotomous qualitative variable: Yes / No.
次要结局
- Glucose(At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.)
- Biological Sex(At enrollment (baseline).)
- Age(At enrollment (baseline).)
- Clinical Judgment(At enrollment (baseline).)
- Prior Pathologies(At enrollment (baseline).)
- Functional Independence(At enrollment (baseline) and 30 days after surgery.)
- Handgrip Strength(At enrollment (baseline) and 30 days after surgery.)
- Nutritional status(At enrollment (baseline), 24 hours before the procedure, and 30 days after surgery.)
- Nutritional Control Index(At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.)
- Malnutrition Diagnosis(At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.)
- Fat mass percentage(At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.)
- Fat-free mass percentage(At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.)
- Total body water(At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.)
- Phase Angle(At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.)
- Body Mass Index(At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.)
- Dietary Intake Percentage(At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.)
- Intervention Adherence(At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.)
- Type of diet(At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.)
- Hemoglobin(At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.)
- Urea(At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.)
- Creatinine(At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.)
- Total Cholesterol(At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.)
- Triglycerides(At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.)
- Total Proteins(At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.)
- Sodium(At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.)
- Potassium(At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.)
- Total Lymphocyte Count(At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.)
- Serum Albumin(At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.)
- Prealbumin(At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.)
- Hospital Length of Stay(From the day of hospital admission for surgery until discharge.)
- Healthcare Costs(From the day of hospital admission for surgery until discharge.)
- Extracellular water(At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.)
- Intracellular water(At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.)
- Cell mass(At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.)
- Limb muscle mass(At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.)
- Muscle mass index(At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.)
- Moisture content percentage(At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.)
研究者
Antonio Jesús Marín Paz
Collaborator Investigator
University of Cadiz