The Effect of Coffee After Resection of Small Bowel

Postoperative Ileus Clinical Trial

Official title:

The Effect of Coffee Consumption on Return to Bowel Function After Small Bowel Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03143621
• Other study ID #: Coffee Small Bowel
• Status: Completed
• Phase: N/A
• Start date: November 15, 2017
• Est. completion date: September 30, 2022

Study information

• Verified date: August 2023
• Source: Mount Carmel Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Post-operative ileus ("post-op ileus") is a condition which can occur after surgery. This means that the bowels stop working correctly and food and liquids will not pass through in the normal manner. Post-op ileus can be uncomfortable and require a longer hospital stay until the bowels begin to function correctly again. Currently there are no effective methods for preventing post-op ileus. Some studies suggest there is a benefit from drinking coffee following colon or gynecological cancer surgeries with very little risk. However, the effects of coffee following small bowel surgery have not been studied. This randomized, controlled trial will compare the outcomes of patients who receive coffee during their hospital stay after small bowel surgery to similar patients who receive warm water. About 60 patients will be in each group. The main outcomes are time until the nasogastric tube is removed and length of hospital stay.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: September 30, 2022
• Est. primary completion date: January 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients undergoing small bowel resection. Can be elective, urgent or emergent.

Exclusion Criteria:

• Patient with atrial fibrillation who is considered a non-coffee drinker (drinks coffee less than 3 days per week over the last 4 weeks)

• Patients undergoing colon resection without removal of any portion of small bowel.

Related Conditions & MeSH terms

• Postoperative Ileus

Intervention

Dietary Supplement:
• Coffee
Brewed, caffeinated coffee, 100 cc's each dose

Other:
• Water
Tap water heated to same temperature as coffee

Locations

Country	Name	City	State
United States	Mount Carmel Health System	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Mount Carmel Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to removal of nasogastric tube	Time at placement to Time at removal through study completion	From date of hospital admission up to date of hospital discharge (anticipated up to 2 weeks)
Secondary	Time to return of bowel function	Time from end of surgery to Time of first flatus or bowel movement through study completion	From date of hospital admission up to date of hospital discharge (anticipated up to 2 weeks)
Secondary	Length of Stay	Time from end of surgery to Time discharge order written	From date of hospital admission up to date of hospital discharge (anticipated up to 2 weeks)