Does Coffee Intake Reduce Postoperative Ileus After Elective Colorectal Surgery

Postoperative Ileus Clinical Trial

— COFFEE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02469441
• Other study ID #: 2014-062
• Status: Completed
• Phase: N/A
• First received: May 29, 2015
• Last updated: January 19, 2017
• Start date: August 1, 2014
• Est. completion date: December 31, 2016

Study information

• Verified date: January 2017
• Source: Kantonsspital Baden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ileus
• Postoperative Ileus

Locations

Country	Name	City	State
Switzerland	Kantonsspital Baden	BAden

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Baden

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first bowel movement	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.	Follow-up per patient: 1 month postoperatively