Effect of the Probiotics Use in Patients Undergoing Surgery for Periampullary Neoplasia - A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
The purpose of this study is to evaluate the effect of the probiotic use in patients with periampullary cancers undergone curative or palliative treatment considering nutritional status, postoperative complications, infection rate, length of hospitalization and mortality.
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)
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 in need of surgery for periampullary cancer
排除标准
- •Patients submitted to periampullary surgery without pathologic confirmation of cancer
- •Patients unwilling to be a part of the trial
研究组 & 干预措施
Sugar pill
The patients submitted to periampullary cancer surgery will receive sugar pills in the preoperative and postoperative period.
干预措施: Sugar pill (Dietary Supplement)
Probiotics
The probiotics pills are given orally in the amount of two pills twice a day as early as two days before surgery until ten days after surgery.
干预措施: Probiotics (Dietary Supplement)
结局指标
主要结局
Mortality
时间窗: participants will be followed for the duration of hospital stay, an expected average of 15 days
Death will be considered as the primary outcome related to complications of surgical treatment in postoperative period
次要结局
- Postoperative infection rate(participants will be followed for the duration of hospital stay, an expected average of 15 days)
研究者
Heloisa Sommacal
nutritionist
Hospital de Clinicas de Porto Alegre