Clinical trial NCT02469441: Does Coffee Intake Reduce Postoperative Ileus After Elective Colorectal Surgery
Official title: Does Coffee Intake Reduce Postoperative Ileus After Elective Colorectal Surgery - a Prospective, Randomized Controlled Study - the COFFEE STUDY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Ileus
Keywords: coffee
postoperative ileus
colorectal surgery
Lead sponsor: Kantonsspital Baden
Sponsor class: OTHER
First posted: 2015-06-11
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with elective colorectal surgery and primary anastomosis \> 6cm above the anal verge without stoma formation

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.

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.

Eligibility 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

Primary outcomes:
measure: Time to first bowel movement
timeFrame: Follow-up per patient: 1 month postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: BAden
country: Switzerland
facility: Kantonsspital Baden
Study officials:
affiliation: Oberärztin
name: Simone Hasler-Gehrer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hasler-Gehrer S, Linecker M, Keerl A, Slieker J, Descloux A, Rosenberg R, Seifert B, Nocito A. Does Coffee Intake Reduce Postoperative Ileus After Laparoscopic Elective Colorectal Surgery? A Prospective, Randomized Controlled Study: The Coffee Study. Dis Colon Rectum. 2019 Aug;62(8):997-1004. doi: 10.1097/DCR.0000000000001405.