Clinical trial · Interventional
Does Caffeine Reduce Postoperative Bowel Paralysis After Elective Colectomy?
Does Caffeine Reduce Postoperative Bowel Paralysis After Elective Colectomy? - A Randomized, Placebo-controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of effect at interims analysis
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasm | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Diverticulitis | — | UNRESOLVED | — |
| Laparoscopic Colectomy Without Stoma Formation | — | UNRESOLVED | — |
| Postoperative Ileus | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Caffeine (100 mg) | Drug | — | UNRESOLVED |
| Caffeine (200 mg) | Drug | — | UNRESOLVED |
| corn starch (250 mg approx.) | Drug | — | UNRESOLVED |
| Radiopaque marker | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Caffeine (100 mg)
- description
- Verum 1 with 100 mg caffeine
- interventionNames
- Drug: Caffeine (100 mg)
- Other: Radiopaque marker
- type
- EXPERIMENTAL
- label
- Caffeine (200 mg)
- description
- Verum 2 with 200 mg caffeine
- interventionNames
- Drug: Caffeine (200 mg)
- Other: Radiopaque marker
- type
- PLACEBO_COMPARATOR
- label
- corn starch (250 mg approx.)
- description
- approx. 250 mg corn starch as placebo
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDMuller SA, Rahbari NN, Schneider F, Warschkow R, Simon T, von Frankenberg M, Bork U, Weitz J, Schmied BM, Buchler MW. Randomized clinical trial on the effect of coffee on postoperative ileus following elective colectomy. Br J Surg. 2012 Nov;99(11):1530-8. doi: 10.1002/bjs.8885. Epub 2012 Sep 14. PMID 22987303
- BACKGROUNDMetcalf AM, Phillips SF, Zinsmeister AR, MacCarty RL, Beart RW, Wolff BG. Simplified assessment of segmental colonic transit. Gastroenterology. 1987 Jan;92(1):40-7. doi: 10.1016/0016-5085(87)90837-7. PMID 3023168
- BACKGROUNDHobi V, Gerhard U, Gutzwiller F. [A report on experiences using Goldberg's GHQ (General Health Questionnaire)]. Schweiz Rundsch Med Prax. 1989 Feb 28;78(9):219-25. German. PMID 2928619
- BACKGROUNDHobi V. Basler Befindlichkeits-Skala. Ein Self-Rating zur Verlaufsmessung der Befindlichkeit. Manual. 1 ed. Weinheim: Beltz Test GmbH, 1985.
- BACKGROUNDParrott AC, Hindmarch I. The Leeds Sleep Evaluation Questionnaire in psychopharmacological investigations - a review. Psychopharmacology (Berl). 1980;71(2):173-9. doi: 10.1007/BF00434408. PMID 6777817
- DERIVEDAbbassi F, Muller SA, Steffen T, Schmied BM, Warschkow R, Beutner U, Tarantino I. Caffeine for intestinal transit after laparoscopic colectomy: randomized clinical trial (CaCo trial). Br J Surg. 2022 Nov 22;109(12):1216-1223. doi: 10.1093/bjs/znac265. PMID 35909263
- DERIVEDKruse C, Muller SA, Warschkow R, Luthi C, Brunner W, Marti L, Sulz MC, Schmied BM, 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 Apr 4;17:186. doi: 10.1186/s13063-016-1297-1. PMID 27044596