Coffee Trial - Does Coffee Intake Reduce Postoperative Ileus After Elective Colectomy?
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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? |
- 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):
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:
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 |
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 More Information
No publications provided by University of Heidelberg
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 University of Heidelberg:
|
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 June 17, 2013