PROSPECTIVE RANDOMIZED CONTROLLED TRIAL ON CLEAR FEEDS VERSUS LOW RESIDUE DIET AFTER SURGERY IN ELECTIVE COLORECTAL SURGERY PATIENTS.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Development of nausea and vomiting on postoperative day two
研究概览
简要总结
Prospective randomized controlled trial investigating commencement of low residue diet versus clear feeds on postoperative day one following elective colorectal surgery, with regards to patient tolerability, incidence of nausea and/or vomiting, and postoperative length of hospitalization stay.
详细描述
Based on current literature, the incidence of postoperative nausea and vomiting varies widely and can reach up to 40% in abdominal surgery patients. Thus, patient tolerability to postoperative enteral feeds is taken as 60%. This is a superiority trial: group one is the clear feeds group and patient tolerability in this group is taken to be 60%. Group two is the low residue diet group.
The primary hypothesis is that the incidence of postoperative ileus is not affected by the consistency of enteral diet given, and patients who are placed on low residue diet from postoperative day one do not have an increased risk of postoperative nausea and vomiting as compared to patients who are placed on clear feeds.
The primary endpoint measured is Patient tolerability, as evidenced by development of vomiting on postoperative day two.
Key Inclusion criteria are:
- Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
- Males or females, >18 years of age inclusive at the time of study screening;
- American Society of Anesthesiologists (ASA) Class I-III;
- Colorectal surgery (open and/or laparoscopic);
- Elective Surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
- •Males or females, >18 years of age inclusive at the time of study screening;
- •American Society of Anesthesiologists (ASA) Class I-III;
- •Colorectal surgery (open and/or laparoscopic);
- •Elective Surgery.
排除标准
- •Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures.
- •Children <18 years of age.
- •Pre-operative clinical diagnosis of intestinal obstruction.
- •Pre-existing known upper gastrointestinal disorders.
- •Pre-existing oropharyngeal disorders such as stomatitis, altered taste sensations.
- •Open upper abdominal surgical incisions.
- •Colorectal surgery with concomitant resectional surgery of the stomach or proximal jejunum (small bowel).
- •Pregnant patients.
- •Bedbound or moribund patients.
- •Pre-existing history of clinical depression.
- •Epidural analgesia.
结局指标
主要结局
Development of nausea and vomiting on postoperative day two
时间窗: postoperative day two
次要结局
未报告次要终点
研究者
Phillip Fleshner MD
Program Director, Colorectal Surgery Fellowship Shierley, Jesslyne, and Emmeline Widjaja Chair in Colorectal Surgery
Cedars-Sinai Medical Center