The Effect of Coffee After Resection of Small Bowel

Not Applicable

Completed

• Conditions: Postoperative Ileus
• Interventions: Dietary Supplement: Coffee; Other: Water

• Registration Number: NCT03143621
• Lead Sponsor: Mount Carmel Health System

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-18
• Study First Submitted QC: 2017-05-04
• Study First Posted: 2017-05-08
• Study Start: 2017-11-15
• Primary Completion: 2022-01-13
• Study Completion: 2022-09-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coffee	Coffee	100 cc's of coffee administered three times per day until return to bowel function has been established.
Water	Water	100 cc's of warm water administered three times per day until return to bowel function has been established.

Primary Outcome Measures

Name	Time	Method
Time to removal of nasogastric tube	From date of hospital admission up to date of hospital discharge (anticipated up to 2 weeks)	Time at placement to Time at removal through study completion

Secondary Outcome Measures

Name	Time	Method
Time to return of bowel function	From date of hospital admission up to date of hospital discharge (anticipated up to 2 weeks)	Time from end of surgery to Time of first flatus or bowel movement through study completion
Length of Stay	From date of hospital admission up to date of hospital discharge (anticipated up to 2 weeks)	Time from end of surgery to Time discharge order written

Trial Locations

Locations (1)

Mount Carmel Health System; 🇺🇸 Columbus, Ohio, United States