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Coffee Trial - Does Coffee Intake Reduce Postoperative Ileus After Elective Colectomy?

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01079442
First Posted: March 3, 2010
Last Update Posted: September 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nuh Rahbari, University of Heidelberg
March 1, 2010
March 3, 2010
September 30, 2011
March 2010
March 2011   (Final data collection date for primary outcome measure)
Time to first bowel movement [ Time Frame: patients postoperative in hospital stay (mean 6 days) ]
Time from end of surgery until patient's first bowel movement (i.e. passage of stool).
Time to first bowel movement [ Time Frame: patients postoperative in hospital stay (mean 6 days) ]
Time from end of surgery until patient's first bowel movement (i.e. passage of solid stool).
Complete list of historical versions of study NCT01079442 on ClinicalTrials.gov Archive Site
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Coffee Trial - Does Coffee Intake Reduce Postoperative Ileus After Elective Colectomy?
Does Coffee Intake Reduce Postoperative Ileus After Elective Colectomy?
The purpose of the investigators study is to investigate the effects of coffee on the return of bowel function and appetite, length of hospital stay, and complications after elective open colectomy in a prospective randomized trial. The primary efficacy endpoint is time to first bowel movement.
Coffee is a popular beverage. Its effects on general well being, central nervous system and cardiovascular system are well known, but there is limited information regarding its effects on gastrointestinal function.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Colectomy
  • Other: Postoperative coffee

    schedule for coffee administration for the present trial was chosen as follows (starting 6 hours postoperatively):

    • 08:00 100mL beverage
    • 12:00 100mL beverage
    • 16:00 100mL beverage
    Other Name: Lavazza Blue Espresso Dolce 100% Arabica coffee
  • Other: water

    The control drink consists of 100 ml warm water which is administered according a same fixed schedule as Group A starting 6 hours postoperatively:

    • 08:00 100mL beverage
    • 12:00 100mL beverage
    • 16:00 100mL beverage
    Other Name: tap water
  • Active Comparator: Treatment arm: coffee
    coffee administration
    Intervention: Other: Postoperative coffee
  • Placebo Comparator: Water arm
    The control drink consists of 100 ml warm water
    Intervention: Other: water
Müller SA, Rahbari NN, Schneider F, Warschkow R, Simon T, von Frankenberg M, Bork U, Weitz J, Schmied BM, Büchler 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
March 2011
March 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients scheduled for elective open or laparoscopic colectomy
  • Age equal or greater than 18 years
  • Informed consent

Exclusion Criteria:

  • Participation in concurrent intervention trials
  • Need for a stoma
  • Known hypersensitivity or allergy to coffee
  • Expected lack of compliance
  • Impaired mental state or language problems
  • change in surgical procedure
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01079442
NNR-6
No
Not Provided
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Nuh Rahbari, University of Heidelberg
Heidelberg University
Not Provided
Not Provided
Heidelberg University
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP