Can Coffee/Caffeine Improve Post-Operative Gastrointestinal Recovery

Can Coffee/Caffeine Improve Post-Operative Gastrointestinal Recovery? A Vanguard Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Caffeine; Postoperative Ileus
• Intervention / Treatment: Other: Coffee; Other: Decaffeinated Coffee; Other: Warm water

Detailed Description

Background/rationale: The development of POI is a common complication of surgery that is detrimental to patient well-being and ultimately leads to significant healthcare costs. Coffee is a popular drink among Canadians and appears to exert a positive effect on GI motility. This beverage may provide an inexpensive, easily administered and well-tolerated intervention to accelerate post-operative GI recovery, and thus reduce POI. The current literature, while promising, is insufficient and merits further investigation in the form of a high-quality randomized controlled trial.

Objectives: Before embarking on a definitive RCT, this pilot trial has five specific feasibility objectives:

1. To assess our ability to accrue patients using the IMPACTS Program platform, at multiple institutions, over the course of one year.
2. To assess our ability to adaptively randomize patients and deliver the randomized assignment using the IMPACTS Program platform, over the course of one year.
3. To assess our ability to collect complete data directly from participants (patients and clinicians) on time to first flatus and time to first bowel movement over the course of one year.
4. To examine our ability to carry out data linkages using the IMPACTS Program platform over the course of one year.
5. To estimate the change in time to first flatus to inform the sample size calculation for the definitive trial.

Study design: This is a multicentre, pragmatic, 3-arm parallel group Vanguard feasibility randomized controlled trial. Patients will be randomly assigned to consume coffee, decaffeinated coffee, or warm water. If feasibility is demonstrated during the pilot trial, we will plan to conduct a definitive trial. If there are only minimal changes to the protocol, we will include data from the pilot phase into the definitive trial analysis (i.e. a Vanguard design).

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • North York, Ontario, Canada, M2K 1E1
      • North York General Hospital
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coffee; Caffeinated coffee beverage	Other: Coffee; 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.
Active Comparator: Decaffeinated coffee; Decaffeinated coffee beverage	Other: Decaffeinated Coffee; 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.
Placebo Comparator: Warm water; Warm water beverage	Other: Warm water; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Median number of hours until flatus in control group; Median number of hours until flatus in coffee and decaffeinated coffee groups	1 year

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Paul Karanicolas, MD PhD, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2021
• Primary Completion (Actual): October 31, 2022
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Coffee; Gastrointestinal motility; Postoperative gastrointestinal recovery
• Other Study ID Numbers: CTO Project ID: 2121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No