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Trial record 11 of 77 for:    coffee

Does Coffee Intake Reduce Postoperative Ileus After Elective Colorectal Surgery (COFFEE)

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ClinicalTrials.gov Identifier: NCT02469441
Recruitment Status : Completed
First Posted : June 11, 2015
Last Update Posted : January 20, 2017
Sponsor:
Information provided by (Responsible Party):
Gehrer Simone, Kantonsspital Baden

Brief Summary:
The aim of the study is to investigate if postoperative coffee intake decreases the time until first bowel movement in elective colorectal surgery with primary anastomosis.

Condition or disease
Postoperative Ileus

Detailed Description:

Postoperative ileus after colorectal surgery is a frequent problem which significantly prolongs hospital stay and increases perioperative costs. Postoperative therapeutic interventions vary significantly between different hospitals due to missing evidence-based guidelines. Coffee is a safe, cheap and simple agent without significant side effects which can positively influence the bowel function.

The aim of the investigators is to evaluate in an own study if coffee consumption has an influence on the duration of postoperative ileus.

The present trial is designed to evaluate if postoperative coffee intake decreases the time until first bowel movement in colorectal surgery with primary anastomosis. This study would be the second study which evaluates the described questions under randomized conditions.


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Study Type : Observational
Actual Enrollment : 136 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Does Coffee Intake Reduce Postoperative Ileus After Elective Colorectal Surgery - a Prospective, Randomized Controlled Study - the COFFEE STUDY
Actual Study Start Date : August 1, 2014
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Group/Cohort
Arm A
Arm A (treatment arm: coffee): patients after colorectal surgery receive coffee in addition to the regular infusion therapy and/or alimentation
Arm B
Arm B (control arm: water / tea): patients after colorectal surgery receive water or tea (excluding black tea) and no coffee until the first bowel movement in addition to the regular infusion therapy and/or alimentation



Primary Outcome Measures :
  1. Time to first bowel movement [ Time Frame: Follow-up per patient: 1 month postoperatively ]
    Time to first bowel movement (time from the end of surgery until the first passage of stool recorded by nursing staff) as a marker for the termination of postoperative ileus.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with elective colorectal surgery and primary anastomosis > 6cm above the anal verge without stoma formation
Criteria

Inclusion Criteria:

Patients scheduled for elective laparoscopic or open colorectal surgery due to benign or malignant colorectal disease, which need a large bowel resection with primary anastomosis

  • Age equal or greater than 18 years
  • Patients that are able to give informed consent
  • Elective Surgery
  • Anastomosis above 6 cm from anal verge

Exclusion Criteria:

  • Participation in other studies
  • Additional small bowel anastomosis
  • Need for extended adhesiolysis
  • Need for a stoma (e.g. protective ileostomy)
  • Emergency operation with diffuse peritonitis or preexisting ileus
  • Preoperative radiation
  • Known hypersensitivity or allergy to coffee
  • Expected lack of compliance
  • Impaired mental state or language problems

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469441


Locations
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Switzerland
Kantonsspital Baden
BAden, Switzerland, 5404
Sponsors and Collaborators
Kantonsspital Baden
Investigators
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Principal Investigator: Simone Hasler-Gehrer, MD Oberärztin

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Responsible Party: Gehrer Simone, Dr. med., Kantonsspital Baden
ClinicalTrials.gov Identifier: NCT02469441     History of Changes
Other Study ID Numbers: 2014-062
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017

Keywords provided by Gehrer Simone, Kantonsspital Baden:
coffee
postoperative ileus
colorectal surgery

Additional relevant MeSH terms:
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Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases