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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nuh Rahbari, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01079442
First received: March 1, 2010
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

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 Intervention
Colectomy
Other: Postoperative coffee
Other: water

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Does Coffee Intake Reduce Postoperative Ileus After Elective Colectomy?

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Time to first bowel movement [ Time Frame: patients postoperative in hospital stay (mean 6 days) ] [ Designated as safety issue: No ]
    Time from end of surgery until patient's first bowel movement (i.e. passage of stool).


Enrollment: 80
Study Start Date: March 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01079442

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

No publications provided by Heidelberg University

Additional 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
Study First Received: March 1, 2010
Last Updated: September 29, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Heidelberg University:
postoperative ileus after colonic resections

Additional relevant MeSH terms:
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 21, 2014