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Completed

NCT Number: NCT02639728

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]

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yosef Nasseri, MD

Los Angeles, California, 90048, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Regular Coffee

Other

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

Decaffeinated coffee

Other

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

Warm water

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2022
Study completion
2022
First posted
Dec 24, 2015
Registry last updated
Nov 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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