Randomized Clinical Trial on the Use of Preoperative Postbiotic Supplementation in Colorectal Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- Postoperative complications within 30 days (Clavien-Dindo grade II or higher)
研究概览
简要总结
The treatment of colorectal cancer, in the absence of metastases, is primarily based on surgical removal. Colorectal surgery, which involves resecting part of the intestine and restoring intestinal continuity, carries a risk of complications. This study aims to evaluate whether oral supplementation with a postbiotic at a dose of 900 mg for 7 days prior to surgery reduces the rate of postoperative complications.
详细描述
Recent studies have underscored the influence of gut microbiota composition on the incidence of postoperative complications following intestinal surgery. Microorganisms naturally present in the intestinal environment produce a variety of substances that may exert either beneficial or detrimental effects on human health. Emerging evidence indicates a protective role for metabolites derived from these microorganisms.
Pharmacological modulation of these metabolites for human supplementation has led to the development of postbiotics. Recent research has demonstrated that certain postbiotics, particularly short-chain fatty acids such as butyrate, possess immunomodulatory properties and contribute to maintaining the integrity of the intestinal barrier in inflammatory bowel disease.
This study will include two groups of participants: one group will receive a daily supplementation of 900 mg of butyrate, while the other will receive a placebo, for seven days prior to surgery. A total of 164 participants are expected to be enrolled, and the study will be conducted over a two-year period.
The present proposal aims to assess the effectiveness of a postbiotic in reducing postoperative complications in colorectal cancer surgery, with an anticipated 50% reduction in the overall postoperative complication rate in the intervention arm. If confirmed, such a reduction would represent a substantial decrease in morbidity and healthcare costs throughout the treatment pathway for this specific population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •Individuals diagnosed with malignant neoplasm of the large intestine, specifically adenocarcinoma.
- •Patients over 18 years of age, of both sexes.
- •Patients who agree to participate in the study and sign the informed consent form.
排除标准
- •Emergency or urgent surgeries.
- •Cytoreductive surgeries involving intraoperative intraperitoneal chemotherapy.
- •Extended surgeries for the treatment of recurrent tumors.
结局指标
主要结局
Postoperative complications within 30 days (Clavien-Dindo grade II or higher)
时间窗: 30 days after colorectal cancer surgery
Clinical or surgical postoperative complication - Clavien-Dindo grade II or higher .
次要结局
- C-reactive protein (CRP) levels after surgery(Baseline (within 7 days before surgery) and postoperative day 3)
- Gastrointestinal postoperative complications (Clavien-Dindo grade II or higher)(30 days after surgery)
- Nutritional status and body composition assessed by preoperative computed tomography(Baseline (preoperative CT scan performed within 8 weeks before surgery); postoperative complications assessed within 30 days after surgery)
- Dietary intake assessment using a Food Frequency Questionnaire (FFQ)(Baseline (preoperative assessment); postoperative complications assessed within 30 days.)
研究者
Samuel Aguiar Jr
MD, PhD, Head of Colorectal Cancer Reference Center at A.C.Camargo Cancer Center
AC Camargo Cancer Center