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OpenTrials
Completed

NCT Number: NCT02469441

Does Coffee Intake Reduce Postoperative Ileus After Elective Colorectal Surgery

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kantonsspital Baden

Baden, 5404, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Kantonsspital Baden

Other

Registry information

Official study title

Does Coffee Intake Reduce Postoperative Ileus After Elective Colorectal Surgery - a Prospective, Randomized Controlled Study - the COFFEE STUDY

Acronym: COFFEE

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 11, 2015
Registry last updated
Jan 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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