Can Coffee/Caffeine Improve Post-Operative Gastrointestinal Recovery

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

Interventions

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.

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.

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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre

  lead OTHER

Principal Investigators

• Paul Karanicolas, MD PhD · Sunnybrook Health Sciences Centre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-05

Primary Completion

2022-07-30

Completion

2022-08-21

Countries

• Canada

Study Locations