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

NCT ID: NCT01079442

Last Updated: 2011-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-03-31

Brief Summary

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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

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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.

Conditions

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Colectomy

Keywords

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postoperative ileus after colonic resections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Treatment arm: coffee

coffee administration

Group Type ACTIVE_COMPARATOR

Postoperative coffee

Intervention Type OTHER

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

Water arm

The control drink consists of 100 ml warm water

Group Type PLACEBO_COMPARATOR

water

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Other Intervention Names

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Lavazza Blue Espresso Dolce 100% Arabica coffee tap water

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Nuh Rahbari

chief resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Salem Krankenhaus

Heidelberg, , Germany

Site Status

University hospital

Heidelberg, , Germany

Site Status

Kreiskrankenhaus GRN Sinsheim

Sinsheim, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 22987303 (View on PubMed)

Other Identifiers

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NNR-6

Identifier Type: -

Identifier Source: org_study_id