Prospective Study of the Effect of Coffee Consumption in Enhancing Recovery of Bowel Function Following Colorectal Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- GI Function
研究概览
简要总结
The effects of coffee have been shown to act as a colonic stimulant. Caffeinated coffee stimulates colonic activity, most notably in the transverse/descending colon, in magnitude similar to a meal, 60% stronger than water, and 23% stronger than decaffeinated coffee. [1] Moreover, the consumption of both water and caffeine causes a decrease in the rectal sensory threshold for the desire to defecate, while anal sphincter pressure after caffeine intake is significantly higher than after water intake. This may result in an earlier desire to defecate. [2] Coffee has also been shown to have an effect on defecation by increasing rectal tone by 45% (measured with a barostat) thirty minutes after consumption. [3]
详细描述
Study Objectives
Primary objective: To determine if the use of coffee in the postoperative period will reduce time to recovery of GI function by at least one day in patients undergoing elective colorectal operations. (This will be assessed by twice daily interview of patients as to whether they have passed flatus or had a bowel movement)
Secondary objective: To determine if the use of coffee in the postoperative period will reduce hospital length of stay by at least one day, and to also evaluate the tolerance of solid food, which will help determine postoperative ileus and rates of vomiting/nasogastric tube (re)insertion, and other perioperative morbidities such as anastomotic leak, wound infection, and intra-abdominal abscesses in patients undergoing elective colorectal operations.
Study Design
This study involves the evaluation of patients who consume coffee compared with patients who consume warm water during the postoperative period after elective colorectal surgery with primary anastomosis.
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
- •• Patients due to undergo small and/or large partial bowel resection via laparotomy or laparoscopy with primary anastomosis. Planned postoperative care includes removing the NG tube at the end of surgery and clear liquid diet of POD #
- •Patients, both male and female, must be between the ages of 18-
- •Patients must be able to freely give written informed consent to participate in the study and have signed the Informed Consent Form.
排除标准
- •• Study patients who do not meet inclusion criteria will not qualify for study inclusion.
- •Patients with a history of prior intestinal surgery, excluding appendectomy.
- •Patients who require an ostomy during their elective colorectal surgery.
- •Patients who require postoperative ventilation, pressors, or ICU stay.
- •Those who are mentally incompetent, unable, or unwilling to provide informed consent or comply with study procedures.
- •American Society of Anesthesiologist (ASA) class IV or V.
- •Those with a history of carcinomatosis.
- •Those with a history of radiation enteritis.
- •Women who are pregnant.
- •Patients who have a history of epilepsy.
- •Patients with prior cardiovascular disorders including uncontrolled hypertension, prior myocardial infarction, or heart failure.
- •Patients with peptic ulcers.
- •Patients with glaucoma.
- •Non-English Speakers.
研究组 & 干预措施
Regular coffee
Will receive a 4oz cup coffee, three times daily (at 8:00, 12:00, and 16:00 hours)and instructed to consume the entirety of its liquid contents. This liquid consumption will begin on the morning of POD #1 at 8:00 hours. Duration of experimental treatment will last until first flatus or bowel movement or 7 days, whichever comes first.
干预措施: Regular Coffee (Other)
Decaffeinated coffee
Will receive a 4oz cup of decaffeinated coffee (at 8:00, 12:00, and 16:00 hours) and instructed to consume the entirety of its liquid contents. This liquid consumption will begin on the morning of POD #1 at 8:00 hours. Duration of experimental treatment will last until first flatus or bowel movement or 7 days, whichever comes first.
干预措施: Decaffeinated coffee (Other)
Warm water
Will receive a 4oz cup of warm water at 8:00, 12:00, and 16:00 hours) and instructed to consume the entirety of its liquid contents. This liquid consumption will begin on the morning of POD #1 at 8:00 hours. Duration of experimental treatment will last until first flatus or bowel movement or 7 days, whichever comes first.
干预措施: Warm water (Other)
结局指标
主要结局
GI Function
时间窗: 30 days
Time to first flatus and/or bowel movement as assessed twice per day by inquiry from the primary team and study investigators.
次要结局
- Abscesses(30 days)
- Hospital Days(30 days)
- Vomiting(30 days)
- Nasogastric tube(30 days)
- Anastomotic leak(30 days)
- Wound Infection(30 days)
研究者
Yosef Nasseri, MD
MD
Cedars-Sinai Medical Center