Prospective Randomized Controlled Trial Investigating Commencement of Low Residue Diet Versus Clear Liquids on Postoperative Zero Following Elective Colorectal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of Participants Who Experienced Emesis on Post Operative Day 2
研究概览
简要总结
Prospective randomized controlled trial investigating commencement of low residue diet versus clear liquids on postoperative zero 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
Offering patients, a low residue diet on the first postoperative day (POD1) after colorectal surgery is safe and improves surgical outcomes and postoperative hospital stay. Early use of low solid is superior to clear liquid diet after elective colorectal surgery.
The purpose of this study is to prospectively evaluate whether providing a patient a solid diet from postoperative day zero is superior to clear liquids. The primary endpoint measured will be patient tolerability, as evidenced by absence of vomiting. The secondary endpoints measured will be duration of supplemental intravenous hydration needed, length of hospital stay and postoperative complications, and intestinal rate measured by Abstats.
Abstats™ consists of a disposable plastic device embedded with a microphone that adheres to the abdominal wall and connects to a computer measuring acoustic event rates. The monitor will be placed on the patient's abdomen 30 minutes prior to surgery in the preoperative holding area to obtain baseline intestinal rate. The monitor will be removed prior to surgery and replaced by the surgical team in the operating room and maintained until postoperative day 3. Daily intestinal rate will be calculated as mean and median acoustic events per minute. The raw data will be analyzed by an investigator blinded to the clinical data. Intestinal rates of patients offered immediate solid feeds will be compared with those offered clear feeds. In addition, patients not tolerating or consuming early solid meal will be compared with those who do to identify whether Abstat™ can be an early predictor of diet intolerance in patients undergoing colorectal surgery.
Patients will be assigned into one of two groups:
Group I - Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 robotic/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 including hiatus hernia, gastroesophageal reflux disease, peptic ulcer disease.
- •Pre-existing oropharyngeal disorders such as stomatitis, altered taste sensations.
- •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.
- •Surgical procedures completed after 4pm
- •Patients taking narcotics prior to elective colorectal surgery
- •Exclusion Criteria After randomization:
- •Postoperative diagnosis of intra-abdominal sepsis, including anastomotic leaks.
- •Postoperative complications requiring early reoperation within the same hospital stay.
结局指标
主要结局
Number of Participants Who Experienced Emesis on Post Operative Day 2
时间窗: POD 2
Patient tolerability, as evidenced by development of vomiting on postoperative day two.
次要结局
- Nausea Score(POD 1 and POD 2 and Discharge)
- Number of Participants Able to Tolerate a Regular Diet as Compared to a Clear Liquid Diet on Post Operative Day 0 (POD 0).(POD 0)
- Hospital Stay(30 days)
- Antiemetic Usage(30 days)
- Post-operative Ileus(30 days)
- Bloating Score(POD 1 and POD 2 and Discharge)
- Pain Score(POD 1 and POD 2 and Discharge)
研究者
Phillip Fleshner MD
Clinical Professor of Surgery
Cedars-Sinai Medical Center