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COFFEE: Does Coffee Intake Reduce Postoperative Ileus After Elective Colorectal Surgery

Sponsor
Kantonsspital Baden (Other)
Overall Status
Completed
CT.gov ID
NCT02469441
Collaborator
(none)
136
Enrollment
1
Location
29
Actual Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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.

    Study Design

    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 :
    Aug 1, 2014
    Actual Primary Completion Date :
    Dec 31, 2016
    Actual Study Completion Date :
    Dec 31, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Time to first bowel movement [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kantonsspital Baden BAden Switzerland 5404

    Sponsors and Collaborators

    • Kantonsspital Baden

    Investigators

    • Principal Investigator: Simone Hasler-Gehrer, MD, Oberärztin

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gehrer Simone, Dr. med., Kantonsspital Baden
    ClinicalTrials.gov Identifier:
    NCT02469441
    Other Study ID Numbers:
    • 2014-062
    First Posted:
    Jun 11, 2015
    Last Update Posted:
    Jan 20, 2017
    Last Verified:
    Jan 1, 2017
    Keywords provided by Gehrer Simone, Dr. med., Kantonsspital Baden
    coffee
    postoperative ileus
    colorectal surgery
    Additional relevant MeSH terms:
    Ileus

    Study Results

    No Results Posted as of Jan 20, 2017