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

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ClinicalTrials.gov Identifier: NCT02639728
Recruitment Status : Unknown
Verified December 2015 by Yosef Nasseri, MD, Cedars-Sinai Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : December 24, 2015
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):
Yosef Nasseri, MD, Cedars-Sinai Medical Center

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]

Condition or disease Intervention/treatment Phase
Postoperative Ileus Other: Regular Coffee Other: Decaffeinated coffee Other: Warm water Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study of the Effect of Coffee Consumption in Enhancing Recovery of Bowel Function Following Colorectal Surgery.
Study Start Date : November 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: 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.
Other: Regular Coffee
Regular coffee will be given a 4oz cup three times daily and will be instructed to consume all of its liquid contents.

Experimental: 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.
Other: Decaffeinated coffee
Decaffeinated coffee will be given a 4oz cup three times daily and will be instructed to consume all of its liquid contents.

Experimental: 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.
Other: Warm water
Warm water will be given a 4oz cup three times daily and will be instructed to consume all of its liquid contents.




Primary Outcome Measures :
  1. GI Function [ 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.


Secondary Outcome Measures :
  1. Hospital Days [ Time Frame: 30 days ]
    Evaluation of length of postoperative hospital stay, will be recorded from medical records.

  2. Vomiting [ Time Frame: 30 days ]
    Evaluation of number of episodes of vomiting will be collected from medical records

  3. Nasogastric tube [ Time Frame: 30 days ]
    Number of nasogastric tube (re)insertion, will be collected from medical records

  4. Anastomotic leak [ Time Frame: 30 days ]
    Evaluation of any anastomotic leak will be collected from medical records

  5. Wound Infection [ Time Frame: 30 days ]
    Evaluation for any wound infection will be collected from medical records

  6. Abscesses [ Time Frame: 30 days ]
    Evaluation for any intra-abdominal abscess will be collected from medical records



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639728


Locations
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United States, California
Yosef Nasseri, MD
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Yosef Nasseri, MD Cedars-Sinai Medical Center