Can Coffee/Caffeine Improve Post-Operative Gastrointestinal Recovery

NCT04547868 | Completed

• 1 other identifier: CTO Project ID: 2121
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 3

Brief Summary

Disruption of the normal gastrointestinal (GI) motility is a well-known consequence of major surgery. The pathophysiology behind this phenomenon is not fully understood but involves the autonomic nervous system as well as a systemic stress response to surgery. A number of factors interfere with GI motor activity, such as the direct manipulation of intestines during surgery and the use of opioid analgesia. Post-operative ileus (POI) refers to a delay in regaining GI motility beyond the anticipated normal duration of time. Signs and symptoms include nausea, vomiting, abdominal distention, the absence of flatus or stool in the preceding 24 hours, and/or an inability to tolerate oral intake. The incidence of POI in abdominal surgery is estimated to be approximately 10%-30%. Beyond increased patient discomfort and distress, the development of POI is associated with increased healthcare costs. Coffee is a popular beverage: two thirds of Canadians are coffee drinkers, averaging approximately 3.2 cups per day. Coffee is composed of hundreds of chemicals, many with demonstrated pharmacologic effects. The most well-known of these compounds is caffeine, known to exert a stimulatory effect on the cardiovascular and nervous system. A recent systematic review of 7 randomized controlled trials (N=606 colorectal and gynecology surgical patients) determined that the consumption of coffee reduced the time of several measures of GI recovery, such as time to tolerance of food, without any increased rate of complications or adverse events although overall, the evidence was graded as low to moderate certainty, and further confirmatory studies are needed. In this trial, patients aged 18 years or higher who undergo laparoscopic or open abdominal surgery, with an estimated length of stay \> 24 hours will be randomized to receive approximately one cup of either coffee, decaffeinated coffee, or warm water, three times daily. This trial will be conducted under the IMPACTS (Innovative, Multicentre, Patient-centred Approach to Clinical Trials in Surgery) program umbrella and will follow IMPACTS methodology. For the Vanguard trial, the aim is to determine the feasibility of conducting a definitive trial. Future outcomes of interest include: time to first flatus, time to first bowel movement, placement of an NG tube, length of stay in hospital, 30-day mortality, and 30-day postoperative complications.

Conditions

Postoperative Ileus; Caffeine

Keywords

Postoperative gastrointestinal recovery; Gastrointestinal motility; Coffee

Outcome Measures

Primary Outcomes (5)

• Assessment of accrual

  Average number of patients enrolled per month across the 3 sites for the trial: feasible if 10 or more

  1 year

• Ability to deliver intervention patient is randomized to receive

  Feasible if \> 90% of patients receive the correct intervention

  1 year

• Ability to collect complete data for patient-reported outcomes

  Feasible if \> 80% of data is collected

  1 year

• Ability to link data from patient-reported outcome measures with Institute for Clinical/Evaluative Sciences and National Surgical Quality Improvement Program datasets

  Feasible if linkage is possible in \> 90% of patients

  1 year

• Measurement of baseline data

  1. Median number of hours until flatus in control group 2. Median number of hours until flatus in coffee and decaffeinated coffee groups

  1 year

Study Arms (3)

Coffee

EXPERIMENTAL

Caffeinated coffee beverage

Other: Coffee

Decaffeinated coffee

ACTIVE COMPARATOR

Decaffeinated coffee beverage

Other: Decaffeinated Coffee

Warm water

PLACEBO COMPARATOR

Warm water beverage

Other: Warm water

Interventions

Coffee OTHER

Once the surgical team deems it appropriate to begin a clear liquid diet (in the post-operative period), approximately one cup of coffee will be provided to the patient three times daily. Additives such as cream, milk, sweetener and sugar, will be permitted. The intervention(s) will continue until a change is required as per the treating team or until hospital discharge. Patients will be asked to avoid any additional caffeine intake, such as tea, for the duration of the trial. If a patient receives an NG tube or is placed NPO by the treating team, the intervention will be halted and restarted once a clear liquid diet is restarted. All other aspects of the patients' care will be at the discretion of the treating team as per their standard practices.

Coffee

Decaffeinated Coffee OTHER

Once the surgical team deems it appropriate to begin a clear liquid diet (in the post-operative period), approximately one cup of decaffeinated coffee will be provided to the patient three times daily. Additives such as cream, milk, sweetener and sugar, will be permitted. The intervention(s) will continue until a change is required as per the treating team or until hospital discharge. Patients will be asked to avoid any additional caffeine intake, such as tea, for the duration of the trial. If a patient receives an NG tube or is placed NPO by the treating team, the intervention will be halted and restarted once a clear liquid diet is restarted. All other aspects of the patients' care will be at the discretion of the treating team as per their standard practices.

Decaffeinated coffee

Warm water OTHER

Once the surgical team deems it appropriate to begin a clear liquid diet (in the post-operative period), approximately one cup of warm water will be provided to the patient three times daily. Additives such as cream, milk, sweetener and sugar, will be permitted. The intervention(s) will continue until a change is required as per the treating team or until hospital discharge. Patients will be asked to avoid any additional caffeine intake, such as tea, for the duration of the trial. If a patient receives an NG tube or is placed NPO by the treating team, the intervention will be halted and restarted once a clear liquid diet is restarted. All other aspects of the patients' care will be at the discretion of the treating team as per their standard practices.

Warm water

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Planned elective laparoscopic or open abdominal surgery
• Patient is scheduled to remain in hospital for at least one night, post-operatively

You may not qualify if:

• Known intolerance to coffee or caffeine
• Unwilling to stop current caffeine consumption (coffee or tea) during trial

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (3)

North York General Hospital

North York, Ontario, M2K 1E1, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Interventions

Coffee

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Paul Karanicolas, MD PhD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Model Details: Pragmatic, multicentre, open-label, three-arm parallel group Vanguard feasibility randomized controlled trial

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 14, 2020
• Study Start: October 5, 2021
• Primary Completion: July 30, 2022
• Study Completion: August 21, 2022
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)