Does Caffeine Reduce Postoperative Bowel Paralysis After Elective Colectomy? (CaCo)

Thomas Steffen

Status: Terminated

Conditions: Laparoscopic Colectomy Without Stoma Formation; Colorectal Neoplasm; Postoperative Ileus; Diverticulitis

Treatments: Drug: Caffeine (100 mg); Drug: Caffeine (200 mg); Drug: corn starch (250 mg approx.); Other: Radiopaque marker

Study type: Interventional

Funder types: Other

Identifiers

NCT02510911

CaCo, Chir201401

Details and patient eligibility

About

Postoperative 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

Caffeine (100 mg)

Experimental group

Description:

Verum 1 with 100 mg caffeine

Treatment:

Other: Radiopaque marker

Drug: Caffeine (100 mg)

Caffeine (200 mg)

Experimental group

Description:

Verum 2 with 200 mg caffeine

Treatment:

Other: Radiopaque marker

Drug: Caffeine (200 mg)

corn starch (250 mg approx.)

Placebo Comparator group

Description:

approx. 250 mg corn starch as placebo

Treatment:

Other: Radiopaque marker

Drug: corn starch (250 mg approx.)