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

November 18, 2022 updated by: Yosef Nasseri, MD, Cedars-Sinai Medical Center

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

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]

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Yosef Nasseri, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: Yosef Nasseri, MD, Cedars-Sinai Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

March 23, 2022

Study Completion (Actual)

March 23, 2022

Study Registration Dates

First Submitted

December 10, 2015

First Submitted That Met QC Criteria

December 22, 2015

First Posted (Estimate)

December 24, 2015

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 18, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00030891

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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