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

September 29, 2011 updated by: Nuh Rahbari, Heidelberg University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • University Hospital
      • Heidelberg, Germany, 69120
        • Salem Krankenhaus
      • Sinsheim, Germany
        • Kreiskrankenhaus GRN Sinsheim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • tap water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
patients postoperative in hospital stay (mean 6 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

March 1, 2010

First Submitted That Met QC Criteria

March 2, 2010

First Posted (Estimate)

March 3, 2010

Study Record Updates

Last Update Posted (Estimate)

September 30, 2011

Last Update Submitted That Met QC Criteria

September 29, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NNR-6

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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