Back to resultsCoffee Trial - Does Coffee Intake Reduce Postoperative Ileus After Elective Colectomy?
Primary Purpose
Colectomy
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Postoperative coffee
water
Sponsored by
About this trial
This is an interventional supportive care trial for Colectomy focused on measuring postoperative ileus after colonic resections
Eligibility 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
Sites / Locations
- Salem Krankenhaus
- University hospital
- Kreiskrankenhaus GRN Sinsheim
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Treatment arm: coffee
Water arm
Arm Description
coffee administration
The control drink consists of 100 ml warm water
Outcomes
Primary Outcome Measures
Time to first bowel movement
Time from end of surgery until patient's first bowel movement (i.e. passage of stool).
Secondary Outcome Measures
Full Information
NCT ID
NCT01079442
First Posted
March 1, 2010
Last Updated
September 29, 2011
Sponsor
Heidelberg University
1. Study Identification
Unique Protocol Identification Number
NCT01079442
Brief Title
Coffee Trial - Does Coffee Intake Reduce Postoperative Ileus After Elective Colectomy?
Official Title
Does Coffee Intake Reduce Postoperative Ileus After Elective Colectomy?
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colectomy
Keywords
postoperative ileus after colonic resections
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment arm: coffee
Arm Type
Active Comparator
Arm Description
coffee administration
Arm Title
Water arm
Arm Type
Placebo Comparator
Arm Description
The control drink consists of 100 ml warm water
Intervention Type
Other
Intervention Name(s)
Postoperative coffee
Other Intervention Name(s)
Lavazza Blue Espresso Dolce 100% Arabica coffee
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
water
Other Intervention Name(s)
tap water
Intervention Description
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
Primary Outcome Measure Information:
Title
Time to first bowel movement
Description
Time from end of surgery until patient's first bowel movement (i.e. passage of stool).
Time Frame
patients postoperative in hospital stay (mean 6 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Salem Krankenhaus
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
University hospital
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Kreiskrankenhaus GRN Sinsheim
City
Sinsheim
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
22987303
Citation
Muller SA, Rahbari NN, Schneider F, Warschkow R, Simon T, von Frankenberg M, Bork U, Weitz J, Schmied BM, Buchler 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.
Results Reference
derived
Learn more about this trial
Coffee Trial - Does Coffee Intake Reduce Postoperative Ileus After Elective Colectomy?
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