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

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ClinicalTrials.gov Identifier: NCT02510911
Recruitment Status : Recruiting
First Posted : July 29, 2015
Last Update Posted : May 10, 2019
Sponsor:
Collaborator:
Gottfried und Julia Bangerter-Rhyner Foundation, Switzerland
Information provided by (Responsible Party):
Thomas Steffen, Cantonal Hospital of St. Gallen

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.


Condition or disease Intervention/treatment Phase
Postoperative Ileus Laparoscopic Colectomy Without Stoma Formation Colorectal Neoplasm Diverticulitis Drug: Caffeine (100 mg) Drug: Caffeine (200 mg) Drug: corn starch (250 mg approx.) Other: Radiopaque marker Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Caffeine Reduce Postoperative Bowel Paralysis After Elective Colectomy? - A Randomized, Placebo-controlled Trial
Study Start Date : August 2015
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Caffeine (100 mg)
Verum 1 with 100 mg caffeine
Drug: 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.

Other Names:
  • 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

Other: 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 Names:
  • Colon Transit
  • PZN 3351272
  • GTIN Code 7629999004153

Experimental: Caffeine (200 mg)
Verum 2 with 200 mg caffeine
Drug: 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.

Other Names:
  • 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

Other: 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 Names:
  • Colon Transit
  • PZN 3351272
  • GTIN Code 7629999004153

Placebo Comparator: corn starch (250 mg approx.)
approx. 250 mg corn starch as placebo
Drug: 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.

Other Name: Amylum maydis

Other: 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 Names:
  • Colon Transit
  • PZN 3351272
  • GTIN Code 7629999004153




Primary Outcome Measures :
  1. Time to first bowel movement [ Time Frame: 7 days ]

    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).



Secondary Outcome Measures :
  1. Time to first flatus [ Time Frame: 7 days ]
    Time from end of surgery until patient's first flatus in hours. The passage of flatus will be determined by questioning the patient; the passage of a bowel movement will be determined by reference to nursing records or by the clinical judgment of the investigator or designee following questioning the patient.

  2. Time to tolerance of solid food [ Time Frame: 7 days ]
    Time from end of surgery until patient tolerates intake of solid food in hours. Tolerance of food is defined as the first time the patient is able to eat solid food (any food re-quiring chewing) without vomiting or significant nausea within 4 h after the meal, and without reversion to only enteral fluids.

  3. Postoperative vomiting events [ Time Frame: 7 days ]
    Number of times patient has to vomit.

  4. Colonic passage time [ Time Frame: 4 days ]
    On day 1, 2 and 3 after surgery patients take one capsule with radioopaque markers. On day 4 location and count of markers is determined by X-ray imaging and the colonic passage time is determined (Metcalf 1987).

  5. Actual postoperative hospital stay [ Time Frame: 30 days ]
    Number of days from surgery until actual discharge.

  6. Theoretical postoperative hospital stay [ Time Frame: 30 days ]

    Days from surgery until patient would be fit for release. Often patients stay longer in hospital than clinically required. Thus, evaluation of theoretical hospital stay.

    A patient is fit for release if:

    • there had been bowel movement
    • solid food is tolerated
    • no serious pain
    • unproblematic mobilisation
    • surgical wound shows no sign of inflammation, or wound can be treated well in an outpatient setting
    • normal inflammatory markers (≤135 mg/l C-reactive protein (CRP), ≤9 10⁹/l white blood cell count)

  7. Daily doses of analgetics [ Time Frame: 30 days ]
    Amount, type, and time of application of analgetics will be obtained from medical and nursing records.

  8. Postoperative pain [ Time Frame: 7 days ]
    evaluated on the numeric rating scale (0 - 10, steps of 1)

  9. Postoperative mobilization [ Time Frame: 7 days ]

    Scoring:

    • 0: 24 h in bed
    • 1: Out of bed only to go to bathroom
    • 2: Out of bed on free will

  10. Overall fluid intake [ Time Frame: 7 days ]
    all fluids in ml per day

  11. Blood pressure [ Time Frame: 7 days ]
    3 times daily

  12. Pulse [ Time Frame: 7 days ]
    3 times daily (or more often if required)

  13. Intensive care [ Time Frame: 14 days ]
    number of days in intensive care unit

  14. Well-being [ Time Frame: 4 days ]
    well-being evaluating on day 2 and 4 after surgery using the Basle mental state scale as well as 5 additional items to evaluate the effects of caffeine. (Hobi 1985, Hobi 1989)

  15. Sleep behaviour [ Time Frame: 4 days ]
    Leeds Sleep Evaluation Questionnaire (LSEQ) on day 2 and 4 after surgery. (Parrott 1986)

  16. Sleeping habits [ Time Frame: 4 days ]
    Questionnaire evaluating duration and deepness of sleep.

  17. Satisfaction with surgery [ Time Frame: 4 days ]
    Questionnaire on day 4 about satisfaction of treatment

  18. Consumption of sleep inducing drugs [ Time Frame: 7 days ]
    amount and type of sleep inducing drugs


Other Outcome Measures:
  1. preoperative caffeine consumption [ Time Frame: before surgery ]
    Questionnaire evaluation the caffeine consumption of patients (type of beverages, amount etc)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02510911


Contacts
Layout table for location contacts
Contact: Thomas Steffen, MD +41 71 494 1111 thomas.steffen@kssg.ch
Contact: Ulrich Beutner, Ph.D. +41 71 494 1328 ulrich.beutner@kssg.ch

Locations
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Switzerland
Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen Not yet recruiting
Rorschach, Switzerland, 9400
Contact: Walter Brunner, MD       walter.brunner@kssg.ch   
Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen Recruiting
St. Gallen, Switzerland, 9007
Principal Investigator: Thomas Steffen, MD         
Sponsors and Collaborators
Thomas Steffen
Gottfried und Julia Bangerter-Rhyner Foundation, Switzerland
Investigators
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Principal Investigator: Thomas Steffen, MD Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Thomas Steffen, Deputy head of department, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT02510911     History of Changes
Other Study ID Numbers: CaCo, Chir201401
First Posted: July 29, 2015    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Thomas Steffen, Cantonal Hospital of St. Gallen:
colectomy
laparoscopy
caffeine
Additional relevant MeSH terms:
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Diverticulitis
Colorectal Neoplasms
Paralysis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Diverticular Diseases
Intraabdominal Infections
Infection
Gastroenteritis
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents