Yosef Nasseri, MD
Los Angeles, California, 90048, United States
NCT Number: NCT02639728
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]
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Los Angeles, California, 90048, United States
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.
This study will be a single-center, randomized trial. Patients who undergo elective colorectal surgery at Cedars-Sinai Medical Center and agree to participate in the study will be randomized 1:1:1 to those who drink regular coffee, decaffeinated coffee, and no coffee. Randomization will occur via an online program (www.randomizer.org), which assigns participants to experimental conditions. The subjects assigned to drink regular coffee, decaffeinated coffee, or warm water will be given a 4oz cup three times daily and will be instructed to consume all of its liquid contents.
Postoperative care will otherwise be the same for all subjects, as dictated by the clinical judgment of the surgical team.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Regular coffee will be given a 4oz cup three times daily and will be instructed to consume all of its liquid contents.
Decaffeinated coffee will be given a 4oz cup three times daily and will be instructed to consume all of its liquid contents.
Warm water will be given a 4oz cup three times daily and will be instructed to consume all of its liquid contents.
Time frame: 30 days
Time to first flatus and/or bowel movement as assessed twice per day by inquiry from the primary team and study investigators.
Time frame: 30 days
Evaluation of length of postoperative hospital stay, will be recorded from medical records.
Time frame: 30 days
Evaluation of number of episodes of vomiting will be collected from medical records
Time frame: 30 days
Number of nasogastric tube (re)insertion, will be collected from medical records
Time frame: 30 days
Evaluation of any anastomotic leak will be collected from medical records
Time frame: 30 days
Evaluation for any wound infection will be collected from medical records
Time frame: 30 days
Evaluation for any intra-abdominal abscess will be collected from medical records
Cedars-Sinai Medical Center
Other
Prospective Study of the Effect of Coffee Consumption in Enhancing Recovery of Bowel Function Following Colorectal Surgery.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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