Does Caffeine Enhance Bowel Recovery After Colorectal Surgery?

Summary

Postoperative ileus is a frequently occurring surgical complication. It is defined as temporary inhibition of propulsive bowel activity and is manifested by abdominal distention, nausea, vomiting and diet intolerance. It may lead to a prolonged hospital stay, hospital-acquired infections or complications that may require additional treatments (e.g. analgesia, fluids, electrolyte replacement, nasogastric tube decompression), and as a result increase medical costs.

Previous studies showed that postoperative coffee consumption shortens the time to first bowel movement after colorectal resections. However, none could explain the mechanism by which coffee stimulates intestinal motility and the determinant agent for this action is still up for discussion (either caffeine or another coffee component).

Coffee has a negligible caloric content; It has a pH that varies from 5 to 6 (less acidity than other beverages that have no similar effect on bowel motility) and it is hypotonic. Therefore, it is highly unlikely that bowel motility is due to the physical properties of the coffee. Much more likely, that one (or more) of the numerous phytochemicals of the coffee bean are responsible for this effect, when the most obvious candidate seems to be caffeine. However, as mentioned above, very little evidence exists that caffeine was responsible for the observed effect on colonic function in previous studies.

The purpose of this single-centered, prospective, single blinded, randomized clinical trial is to evaluate whether the use of caffeine in the post-operative period significantly reduces the duration of postoperative ileus, and therefore, improves recovery and shorten the hospital stay.

The study hypothesis is that post-operative use of caffeine will reduce time to recovery of GI function (post-operative ileus) by at least 15 hours and thus reduce hospital length of stay by at least 15 hours in patients undergoing elective colorectal operations.

50 patients due to undergo large bowel resection via laparotomy or laparoscopy will be enrolled and randomized (1:1) to those who will receive caffeine (100 mg 3 times per day) and those who will receive placebo (tap water) starting on the morning of postoperative day 1 after surgery until flatus will occur for the first time or to a maximal period time of 7 days, whichever comes earlier.

Conditions

• Postoperative Ileus

Interventions

DRUG

Caffeine Citrate

25 patients after elective colorectal surgery will be given 100 mg caffeine citrate orally diluted in 50 ml apple flavored water three times per day starting on the morning of postoperative day 1 after surgery until flatus will occur for the first time or to a maximal period time of 7 days, whichever comes earlier.

OTHER

Water

25 patients after elective colorectal surgery will be given 50 ml apple flavored water three times per day starting on the morning of postoperative day 1 after surgery until flatus will occur for the first time or to a maximal period time of 7 days, whichever comes earlier.

Sponsors & Collaborators

• Hadassah Medical Organization

  lead OTHER

Principal Investigators

• Noam Shussman, MD · Hadassah Medical Organization

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-02

Primary Completion

2019-12-31

Completion

2019-12-31

Countries

• Israel