Coffee Trial - Does Coffee Intake Reduce Postoperative Ileus After Elective Colectomy?
Does Coffee Intake Reduce Postoperative Ileus After Elective Colectomy?
1 other identifier
interventional
80
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2010
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedFirst Posted
Study publicly available on registry
March 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedSeptember 30, 2011
September 1, 2011
1 year
March 1, 2010
September 29, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to first bowel movement
Time from end of surgery until patient's first bowel movement (i.e. passage of stool).
patients postoperative in hospital stay (mean 6 days)
Study Arms (2)
Treatment arm: coffee
ACTIVE COMPARATORcoffee administration
Water arm
PLACEBO COMPARATORThe control drink consists of 100 ml warm water
Interventions
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
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
Eligibility Criteria
You may qualify if:
- Patients scheduled for elective open or laparoscopic colectomy
- Age equal or greater than 18 years
- Informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Salem Krankenhaus
Heidelberg, 69120, Germany
University hospital
Heidelberg, 69120, Germany
Kreiskrankenhaus GRN Sinsheim
Sinsheim, Germany
Related Publications (1)
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.
PMID: 22987303DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- chief resident
Study Record Dates
First Submitted
March 1, 2010
First Posted
March 3, 2010
Study Start
March 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
September 30, 2011
Record last verified: 2011-09