Postoperative bowel paralysis is common after abdominal operations,
including colectomy. As a result, hospitalization may be prolonged,
thereby leading to increased cost. A recent randomized controlled
trial showed that the consumption of regular black coffee after
colectomy is associated with a significantly faster resumption of
intestinal motility. The mechanism by which coffee stimulates
intestinal motility is unknown, but caffeine seems to be the most
likely stimulating agent. Thus, the effect of caffeine on
postoperative bowel activity after colon surgery will be analyzed in
this trial, herein referred to as CaCo.
Patients scheduled for elective laparoscopic colectomy or upper
rectum resection are eligible to participate in this double-blinded,
placebo-controlled, randomized trial. Patients fulfilling all
inclusion criteria will be allocated after the surgical procedure to
one of three treatment arms: 100 mg caffeine, 200 mg
caffeine, or placebo (corn starch). Patients will take the capsules
containing the study medication three times daily with a meal. The
primary endpoint of the study is the time to a solid bowel movement.
The study treatment will be stopped after the patient produces a
solid bowel movement or has taken ten capsules, whichever occurs
first. To determine the colonic passage time, patients will take a
capsule with radiopaque markers at breakfast for the first
3 days after surgery. On the fourth day, the location of the
markers will be determined with an abdominal X-ray scan. Further
secondary objectives are the postoperative morbidity and mortality,
well-being, sleeping behavior, and length of hospital stay. The
study size was calculated to be 180 patients with an interim
analysis occurring after 60 patients.
From a previous study investigating coffee, evidence exists that
caffeine might have a positive influence on the postoperative bowel
activity. This double-blinded, placebo-controlled, randomized trial
tries to show that caffeine will shorten the postoperative bowel
paralysis and, thus, will improve recovery and shorten the hospital
stay after colon surgery.
Clinicaltrials.gov NCT02510911 Swiss National Clinical Trials Portal
Koffein, Caffeine, Dickdarm, Colon, Ileus, Darmparalyse, randomisierte, kontrollierte Studie, RCT
Kruse C, mueller s, Warschkow R, luethi c, Brunner W, Marti L, Sulz
M, Schmied B M, Tarantino I, Beutner U. Does caffeine reduce
postoperative bowel paralysis after elective laparoscopic colectomy?
(CaCo trial): study protocol for a randomized controlled trial.
Trials 2016; 17:186.