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

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ClinicalTrials.gov Identifier: NCT01079442
Recruitment Status : Completed
First Posted : March 3, 2010
Last Update Posted : September 30, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Colectomy Other: Postoperative coffee Other: water

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Does Coffee Intake Reduce Postoperative Ileus After Elective Colectomy?
Study Start Date : March 2010
Primary Completion Date : March 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Treatment arm: coffee
coffee administration
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
Placebo Comparator: Water arm
The control drink consists of 100 ml warm water
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


Outcome Measures

Primary Outcome Measures :
  1. 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).


Eligibility Criteria

Information from the National Library of Medicine

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

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
Contacts and Locations

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): NCT01079442


Locations
Germany
Salem Krankenhaus
Heidelberg, Germany, 69120
University hospital
Heidelberg, Germany, 69120
Kreiskrankenhaus GRN Sinsheim
Sinsheim, Germany
Sponsors and Collaborators
Heidelberg University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nuh Rahbari, chief resident, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01079442     History of Changes
Other Study ID Numbers: NNR-6
First Posted: March 3, 2010    Key Record Dates
Last Update Posted: September 30, 2011
Last Verified: September 2011

Keywords provided by Nuh Rahbari, University of Heidelberg:
postoperative ileus after colonic resections