Does Caffeine Reduce Postoperative Bowel Paralysis After Elective Colectomy?
NCT ID: NCT02510911
Last Updated: 2021-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
60 participants
INTERVENTIONAL
2015-08-31
2020-12-22
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Caffeine (100 mg)
Verum 1 with 100 mg caffeine
Caffeine (100 mg)
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.
Radiopaque marker
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%).
Caffeine (200 mg)
Verum 2 with 200 mg caffeine
Caffeine (200 mg)
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.
Radiopaque marker
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%).
corn starch (250 mg approx.)
approx. 250 mg corn starch as placebo
corn starch (250 mg approx.)
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.
Radiopaque marker
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%).
Interventions
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Caffeine (100 mg)
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.
Caffeine (200 mg)
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.
corn starch (250 mg approx.)
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.
Radiopaque marker
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%).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Gottfried und Julia Bangerter- Rhyner-Stiftung, Basel
OTHER
Thomas Steffen
OTHER
Responsible Party
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Thomas Steffen
Deputy head of department
Principal Investigators
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Thomas Steffen, MD
Role: PRINCIPAL_INVESTIGATOR
Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen
Locations
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Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen
Rorschach, , Switzerland
Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen
Sankt Gallen, , Switzerland
Countries
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References
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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.
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.
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.
Hobi V. Basler Befindlichkeits-Skala. Ein Self-Rating zur Verlaufsmessung der Befindlichkeit. Manual. 1 ed. Weinheim: Beltz Test GmbH, 1985.
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.
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.
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.
Related Links
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Web site of the Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen (German only)
Other Identifiers
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CaCo, Chir201401
Identifier Type: -
Identifier Source: org_study_id
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