The Effect of Coffee Consumption in Enhancing Recovery of Bowel Function Following Colorectal Surgery.

Study Overview
=================
Brief Summary
-----------------
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]

Detailed Description
-----------------
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.

Official Title
-----------------
Prospective Study of the Effect of Coffee Consumption in Enhancing Recovery of Bowel Function Following Colorectal Surgery.

Conditions
-----------------
Postoperative Ileus

Intervention / Treatment
-----------------
* Other: Regular Coffee
* Other: Decaffeinated coffee
* Other: Warm water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • 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 #1. Patients, both male and female, must be between the ages of 18-85. Patients must be able to freely give written informed consent to participate in the study and have signed the Informed Consent Form. Exclusion Criteria: • 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regular coffee<br>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. | Other: Regular Coffee<br>* Regular coffee will be given a 4oz cup three times daily and will be instructed to consume all of its liquid contents.<br>|
| Experimental: Decaffeinated coffee<br>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. | Other: Decaffeinated coffee<br>* Decaffeinated coffee will be given a 4oz cup three times daily and will be instructed to consume all of its liquid contents.<br>|
| Experimental: Warm water<br>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. | Other: Warm water<br>* Warm water will be given a 4oz cup three times daily and will be instructed to consume all of its liquid contents.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI Function | Time to first flatus and/or bowel movement as assessed twice per day by inquiry from the primary team and study investigators. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Days | Evaluation of length of postoperative hospital stay, will be recorded from medical records. | 30 days | 
| Vomiting | Evaluation of number of episodes of vomiting will be collected from medical records | 30 days | 
| Nasogastric tube | Number of nasogastric tube (re)insertion, will be collected from medical records | 30 days | 
| Anastomotic leak | Evaluation of any anastomotic leak will be collected from medical records | 30 days | 
| Wound Infection | Evaluation for any wound infection will be collected from medical records | 30 days | 
| Abscesses | Evaluation for any intra-abdominal abscess will be collected from medical records | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bowel surgery, Postoperative bowel recovery