Intestinal Function of Patients With Colon Neoplasia, Airways and Upper Digestives Subjected to Surgical Treatment: Impact of the Use of Symbiotics
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 42
- 试验地点
- 3
- 主要终点
- Diarrhea occurrence
研究概览
简要总结
Due to the high incidence, cancer and the concomitant presence of malnutrition are currently a worldwide public health problem. The loss of weight and body tissues is a common condition in cancer patients with lesions of the airways and digestive tract and is related to anorexia and the presence and duration of gastrointestinal symptoms, such as diarrhea. The latter directly interferes with the progression of enteral diets, which are administered in order to provide adequate nutritional support for the recovery of patients and nutritional status. In this sense, the importance of measures to help reduce diarrhea episodes is reinforced, aiming at the adequate infusion of enteral diets and, consequently, nutritional needs. It is known that the use of antimicrobials is closely related to the increased incidence of nasocomial diarrhea, as it facilitates colonization by pathogenic bacteria, such as Clostridium difficile. In addition, nosocomial diarrhea is a very relevant occurrence due to the financial burden it causes for the hospital institution, which can also worsen the patient's clinical condition, since he is weakened due to the underlying disease. Despite these important aspects, studies carried out with the aim of reducing diarrhea episodes in patients with airway and digestive lesions are still not described in the literature. In this context, the use of symbiotics presents itself as a possibly beneficial alternative, considering the role of probiotics and prebiotics in the modulation of intestinal function. In this sense, this work aims to evaluate the impact of perioperative supplementation with symbiotic on clinical outcomes and intestinal function of patients with colon cancer and digestive airways undergoing colorectal resection. It is assumed that the use of symbiotics could have better results than the use of probiotics and isolated prebiotics.
详细描述
Most cancer patients have a compromised nutritional status, 80% are malnourished at the time of the initial diagnosis. It is known that in patients with airway and digestive cancer the risk of malnutrition is increased, due to changes caused by the location of the tumor such as dysphagia, odynophagia and changes in taste.
The clinical effects of malnutrition are manifested by difficulty in healing after surgery, increased risk of infection and treatment toxicity, in addition to greater demand for care and hospital costs. Therefore, it is of utmost importance to provide adequate nutritional needs to these patients, since adequate nutritional therapy (NT) is able to improve their clinical response and prognosis.
Nutritional support is seen as an important strategy for the treatment and recovery of these patients, since it promotes greater adequacy of nutritional support, improving nutritional status as well as response to treatment and immune function, in addition to improving quality of life and reducing hospital costs. However, gastrointestinal complications, such as diarrhea, represent important causes for not receiving the planned enteral diet volume, or the patient's intake inadequacy, which causes an insufficient supply of calories, proteins, vitamins and minerals over the days, contributing with worsening nutritional status, as well as increased hospital stay and costs with hospitalization.
Diarrhea affects about 16% to 63% of patients on enteral nutrition. The most frequent causes of diarrhea in cancer patients are related to medications, such as antibiotics, antacids with magnesium, lactulose, laxatives, supplements with potassium and phosphorus and medications with sorbitol6. Other possible causes of diarrhea include hypoalbuminemia, rapid infusion and intolerance to some component of the diet, infectious causes such as the presence of Clostridium difficile, severe malnutrition and, more rarely with the use of industrialized diets, bacterial contamination of the enteral formula.
In particular, the presence of nosocomial diarrhea - defined as infectious diarrhea acquired in a hospital environment - increases the length of stay of patients (eight days, on average), increases the likelihood of infections in surgical wounds, and consequently, hospital mortality. Among the identifiable causes of this type of diarrhea, the indiscriminate use of antimicrobials has been identified as an important predisposing factor, particularly in facilitating colonization and intestinal infection by Clostridium difficile. This bacterium has an incidence between 5% and 39%, with an increased incidence in hospitalized post-surgical patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All individuals directly involved in the research will be masked. The modules used in the study were masked by an individual external to the research, being the only one who knew the composition.
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 over 18 years of age, diagnosed with colorectal and head and neck cancer who will undergo a tumor resection operation
排除标准
- •Individuals who have inflammatory bowel diseases will be excluded; have previously undergone operations on the gastrointestinal tract; have used antibiotics, prebiotics, probiotics or symbiotics in the last 15 days and are on an enteral fiber diet.
结局指标
主要结局
Diarrhea occurrence
时间窗: Through study completion, an average of 2 years
Assess the incidence of diarrhea by collecting information on the frequency and consistency of stools. Stool consistency will be classified using the Bristol scale.
次要结局
- Operative complications(Through study completion, an average of 2 years)
- Nutritional status(Through study completion, an average of 2 years)
研究者
Maria Isabel Toulson Davisson Correia
Sponsor-Investigator
Federal University of Minas Gerais