Coffee Trial - Does Coffee Intake Reduce Postoperative Ileus After Elective Colectomy?

Colectomy Clinical Trial

Official title:

Does Coffee Intake Reduce Postoperative Ileus After Elective Colectomy?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01079442
• Other study ID #: NNR-6
• Status: Completed
• Phase: N/A
• First received: March 1, 2010
• Last updated: September 29, 2011
• Start date: March 2010
• Est. completion date: March 2011

Study information

• Verified date: September 2011
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of the investigators study is to investigate the effects of coffee on the return of bowel function and appetite, length of hospital stay, and complications after elective open colectomy in a prospective randomized trial. The primary efficacy endpoint is time to first bowel movement.

Description:

Coffee is a popular beverage. Its effects on general well being, central nervous system and cardiovascular system are well known, but there is limited information regarding its effects on gastrointestinal function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients scheduled for elective open or laparoscopic colectomy

• Age equal or greater than 18 years

• Informed consent

Exclusion Criteria:

• Participation in concurrent intervention trials

• Need for a stoma

• Known hypersensitivity or allergy to coffee

• Expected lack of compliance

• Impaired mental state or language problems

• change in surgical procedure

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colectomy

Intervention

Other:
• Postoperative coffee
schedule for coffee administration for the present trial was chosen as follows (starting 6 hours postoperatively): 08:00 100mL beverage 12:00 100mL beverage 16:00 100mL beverage
• water
The control drink consists of 100 ml warm water which is administered according a same fixed schedule as Group A starting 6 hours postoperatively: 08:00 100mL beverage 12:00 100mL beverage 16:00 100mL beverage

Locations

Country	Name	City	State
Germany	Salem Krankenhaus	Heidelberg
Germany	University hospital	Heidelberg
Germany	Kreiskrankenhaus GRN Sinsheim	Sinsheim

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first bowel movement	Time from end of surgery until patient's first bowel movement (i.e. passage of stool).	patients postoperative in hospital stay (mean 6 days)	No