Does Coffee Intake Reduce Postoperative Ileus After Elective Colorectal Surgery

NCT02469441 | Completed DMC

• 1 other identifier: 2014-062
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Ileus

Keywords

coffee; postoperative ileus; colorectal surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with elective colorectal surgery and primary anastomosis \> 6cm above the anal verge without stoma formation

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kantonsspital Baden: lead

Study Sites (1)

Kantonsspital Baden

Baden, 5404, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 30998528 DERIVED

Study Officials

• Simone Hasler-Gehrer, MD

  Oberärztin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: June 11, 2015
• Study Start: August 1, 2014
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: January 20, 2017

Record last verified: 2017-01

Locations

CH (1)