Clinical trial NCT02510911: Does Caffeine Reduce Postoperative Bowel Paralysis After Elective Colectomy?
Official title: Does Caffeine Reduce Postoperative Bowel Paralysis After Elective Colectomy? - A Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Postoperative Ileus
Laparoscopic Colectomy Without Stoma Formation
Colorectal Neoplasm
Diverticulitis
Keywords: colectomy
laparoscopy
caffeine
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
Collaborators: name: Gottfried und Julia Bangerter- Rhyner-Stiftung, Basel
First posted: 2015-07-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to first bowel movement
timeFrame: 7 days
Secondary outcomes:
measure: Time to first flatus
timeFrame: 7 days
measure: Time to tolerance of solid food
timeFrame: 7 days
measure: Postoperative vomiting events
timeFrame: 7 days
measure: Colonic passage time
timeFrame: 4 days
measure: Actual postoperative hospital stay
timeFrame: 30 days
measure: Theoretical postoperative hospital stay
timeFrame: 30 days
measure: Daily doses of analgetics
timeFrame: 30 days
measure: Postoperative pain
timeFrame: 7 days
measure: Postoperative mobilization
timeFrame: 7 days
measure: Overall fluid intake
timeFrame: 7 days
measure: Blood pressure
timeFrame: 7 days
measure: Pulse
timeFrame: 7 days
measure: Intensive care
timeFrame: 14 days
measure: Well-being
timeFrame: 4 days
measure: Sleep behaviour
timeFrame: 4 days
measure: Sleeping habits
timeFrame: 4 days
measure: Satisfaction with surgery
timeFrame: 4 days
measure: Consumption of sleep inducing drugs
timeFrame: 7 days
Other outcomes:
measure: preoperative caffeine consumption
timeFrame: before surgery
Locations:
city: Rorschach
country: Switzerland
facility: Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen
city: St. Gallen
country: Switzerland
facility: Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen
Study officials:
affiliation: Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen
name: Thomas Steffen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muller 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.
citation: Metcalf 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.
citation: Hobi 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.
citation: Hobi V. Basler Befindlichkeits-Skala. Ein Self-Rating zur Verlaufsmessung der Befindlichkeit. Manual. 1 ed. Weinheim: Beltz Test GmbH, 1985.
citation: Parrott AC, Hindmarch I. The Leeds Sleep Evaluation Questionnaire in psychopharmacological investigations - a review. Psychopharmacology (Berl). 1980;71(2):173-9. doi: 10.1007/BF00434408.
citation: Abbassi 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.
citation: Kruse 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.