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

History of Changes

Tracking Information
First Received Date ^ICMJE	March 1, 2010
Last Updated Date	September 29, 2011
Start Date ^ICMJE	March 2010
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 29, 2011)	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).
Original Primary Outcome Measures ^ICMJE (submitted: March 2, 2010)	Time to first bowel movement [ Time Frame: patients postoperative in hospital stay (mean 6 days) ] [ Designated as safety issue: Yes ] Time from end of surgery until patient's first bowel movement (i.e. passage of solid stool).
Change History	Complete list of historical versions of study NCT01079442 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Coffee Trial - Does Coffee Intake Reduce Postoperative Ileus After Elective Colectomy?
Official Title ^ICMJE	Does Coffee Intake Reduce Postoperative Ileus After Elective Colectomy?
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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Condition ^ICMJE	Colectomy
Intervention ^ICMJE	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
Study Arm (s)	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
Publications *	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.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	80
Completion Date	March 2011
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01079442
Other Study ID Numbers ^ICMJE	NNR-6
Has Data Monitoring Committee	No
Responsible Party	Nuh Rahbari, University of Heidelberg
Study Sponsor ^ICMJE	University of Heidelberg
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Heidelberg
Verification Date	September 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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