Change in Incidence of Surgical Site Infection After Resection of Colorectal Cancer Between Patients Receiving a Symbiotic Compound and Patients Receiving a Placebo.
试验速览
- 阶段
- 不适用
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Number of participants with colorectal cancer on symbiotic to prevent postoperative infection
研究概览
简要总结
This is a double blind randomized trial in which patients with colorectal cancer undergoing surgery will be selected to receive either a symbiotic formulation or placebo. The researchers will compare incidence of surgical site infection between the study groups.
详细描述
This is a double blind randomized trial in which patients with colorectal cancer undergoing surgery will be randomly selected to receive either a symbiotic formulation or placebo during the perioperative period. The researchers will compare incidence of surgical site infection, detected by clinical examination and complementary tests (CT scans, X-rays, microbiological and hematological tests) between the study groups.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between 18 and 85 years old;
- •Colorectal cancer patients.
- •Ability to understand and signing the informed consent
排除标准
- •Pregnancy (early diagnosis)
- •Reduced intellectual level that could prevent proper understanding of the objectives of the study
- •Patients with rectal cancer undergoing neoadjuvant treatment (chemotherapy and radiotherapy)
- •Use of products with prebiotic, probiotic and / or symbiotic function or fiber module; by more than 3x a week
- •Refusal to participate and / or to sign the Consent Form Free and Clear
结局指标
主要结局
Number of participants with colorectal cancer on symbiotic to prevent postoperative infection
时间窗: 1 month
This is a double blind randomized trial in which patients with colorectal cancer undergoing surgery will be selected to receive either a symbiotic formulation or placebo. After we will compare the number of participants with incidence of surgical site infection between the study groups.
次要结局
未报告次要终点
研究者
Aline Gamarra Taborda
ms
Hospital de Clinicas de Porto Alegre