Title
Does Caffeine Reduce Postoperative Bowel Paralysis After Elective Colectomy?
Does Caffeine Reduce Postoperative Bowel Paralysis After Elective Colectomy? - A Randomized, Placebo-controlled Trial
Phase
N/ALead Sponsor
Cantonal Hospital of St. GallenStudy Type
InterventionalStatus
TerminatedStudy Participants
60Postoperative bowel paralysis is common after abdominal operations, including colectomy. As a result, hospitalization may be prolonged leading to increased cost. A recent randomized controlled trial from the University of Heidelberg showed that consumption of regular black coffee after colectomy is safe and associated with a significantly faster resumption of intestinal motility (Müller 2012). The mechanism how coffee stimulates intestinal motility is unknown but caffeine seems to be the most likely stimulating agent.
Thus, this trial addresses the question: Does caffeine reduce postoperative bowel paralysis after elective laparoscopic colectomy?
Patients after laparoscopic colectomy will receive either 100 mg caffeine, 200 mg caffeine, or 250mg corn starch (placebo) 3 times daily in identically looking gelatin capsules.
The study is a randomized, controlled trial, with blinding of physicians, patients and nursing stuff (evaluating the endpoints).
Primary endpoint will be the time to first bowel movement.
Patients after laparoscopic colectomy will receive 3 times daily capsules with 100 mg caffeine together with the meals. First capsule will be taken on the evening of surgery if surgery was completed before 1 pm, otherwise the first capsule will be taken on the morning of the next day. Treatment consists of 10 capsules and will be stopped after the first solid bowel movement.
Patients after laparoscopic colectomy will receive 3 times daily capsules with 200 mg caffeine together with the meals. First capsule will be taken on the evening of surgery if surgery was completed before 1 pm, otherwise the first capsule will be taken on the morning of the next day. Treatment consists of 10 capsules and will be stopped after the first solid bowel movement.
Patients after laparoscopic colectomy will receive 3 times daily capsules with 250 mg corn starch together with the meals. First capsule will be taken on the evening of surgery if surgery was completed before 1 pm, otherwise the first capsule will be taken on the morning of the next day. Treatment consists of 10 capsules and will be stopped after the first solid bowel movement.
On the morning of the first, second and third day after surgery patients will take 1 capsule each day with radiopaque markers . On day 4 after surgery an abdominal X-ray will be performed to localize the markers. Each gelatin capsule contains 10 markers consisting of polyurethane encapsulated barium sulfate (40%).
Verum 1 with 100 mg caffeine
Verum 2 with 200 mg caffeine
approx. 250 mg corn starch as placebo
Inclusion Criteria: Patients scheduled for elective laparoscopic colectomy (right or left hemicolectomy, segmental resection, extended hemicolectomy, sigmoid resection, upper rectum (anastomosis higher than 7 cm ab ano)) There will be no upper age limit. If elderly patients are considered fit for surgery, they will be included in the study. Informed consent Application of epidural analgesia Exclusion Criteria: Participation in another concurrent interventional trial Need for a stoma (colostomy or ileostomy) or reversal of a stoma, if the patient had a complete bowel obstruction Known hypersensitivity or allergy to caffeine/coffee Expected lack of compliance American Society of Anesthesiologists (ASA) Physical Status Score of IV or V Impaired mental state or language problems Alcoholism or drug abuse Previous extensive abdominal surgery Inflammatory bowel disease Clinically significant cardiac arrhythmia Cardiac insufficiency Pregnancy, lactation, or childbearing potential without using adequate contraception Intake of opioid analgesics, or steroids >5mg/d for ≥7 days before surgery Under anti-depressive medication Liver cirrhosis or compromised liver function (MELD score >15) Emergency procedure
