Does Caffeine Reduce Postoperative Bowel Paralysis After Elective Colectomy?

NCT02510911 | Terminated DMC

• 1 other identifier: CaCo, Chir201401
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

colectomy; laparoscopy; caffeine

Outcome Measures

Primary Outcomes (1)

• Time to first bowel movement

  Time from end of surgery (time of closing suture) until patient's first bowel movement (passage of stool) in hours. A patient is considered to have met the primary endpoint when he or she had first tolerated food (recovery of upper GI function) and experienced a bowel movement for the first time (recovery of lower GI function).

  7 days

Secondary Outcomes (18)

• Time to first flatus

  7 days

• Time to tolerance of solid food

  7 days

• Postoperative vomiting events

  7 days

• Colonic passage time

  4 days

• Actual postoperative hospital stay

  30 days

Other Outcomes (1)

• preoperative caffeine consumption

  before surgery

Study Arms (3)

Caffeine (100 mg)

EXPERIMENTAL

Verum 1 with 100 mg caffeine

Drug: Caffeine (100 mg); Other: Radiopaque marker

Caffeine (200 mg)

EXPERIMENTAL

Verum 2 with 200 mg caffeine

Drug: Caffeine (200 mg); Other: Radiopaque marker

corn starch (250 mg approx.)

PLACEBO COMPARATOR

approx. 250 mg corn starch as placebo

Drug: corn starch (250 mg approx.); Other: Radiopaque marker

Interventions

Caffeine (100 mg) DRUG

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.

Also known as: coffeinum, methyltheobromine, 1,3,7-trimethyl-3,7-dihydro-1H-purin-2,4-dion, CAS No: 56-08-2, Ph.Eur: 6.0/027, ATC code: N06BC01

Caffeine (100 mg)

Caffeine (200 mg) DRUG

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.

Also known as: coffeinum, methyltheobromine, 1,3,7-trimethyl-3,7-dihydro-1H-purin-2,4-dion, CAS No: 56-08-2, Ph.Eur: 6.0/027, ATC code: N06BC01

Caffeine (200 mg)

corn starch (250 mg approx.) DRUG

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.

Also known as: Amylum maydis

corn starch (250 mg approx.)

Radiopaque marker OTHER

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%).

Also known as: Colon Transit, PZN 3351272, GTIN Code 7629999004153

Caffeine (100 mg); Caffeine (200 mg); corn starch (250 mg approx.)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Thomas Steffen: lead
• Gottfried und Julia Bangerter- Rhyner-Stiftung, Basel: collaborator

Study Sites (2)

Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen

Rorschach, 9400, Switzerland

Location

Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Related Publications (7)

• 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.

  PMID: 22987303 BACKGROUND

• 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.

  PMID: 3023168 BACKGROUND

• 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.

  PMID: 2928619 BACKGROUND

• Hobi V. Basler Befindlichkeits-Skala. Ein Self-Rating zur Verlaufsmessung der Befindlichkeit. Manual. 1 ed. Weinheim: Beltz Test GmbH, 1985.

  BACKGROUND

• 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.

  PMID: 6777817 BACKGROUND

• 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.

  PMID: 35909263 DERIVED

• 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.

  PMID: 27044596 DERIVED

Related Links

• Web site of the Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen (German only)

MeSH Terms

Conditions

Colorectal Neoplasms; Diverticulitis

Interventions

Caffeine; Starch

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Diverticular Diseases; Gastroenteritis

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Thomas Steffen, MD

  Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy head of department

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: July 29, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2020
• Study Completion: December 22, 2020
• Last Updated: August 4, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)