The Effect of Coffee After Resection of Small Bowel

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Ileus
• Intervention / Treatment: Dietary supplement: Coffee; Other: Water

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Mount Carmel Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coffee; 100 cc's of coffee administered three times per day until return to bowel function has been established.	Dietary supplement: Coffee; Brewed, caffeinated coffee, 100 cc's each dose
Placebo Comparator: Water; 100 cc's of warm water administered three times per day until return to bowel function has been established.	Other: Water; Tap water heated to same temperature as coffee

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Mount Carmel Health System
• Investigators: Principal Investigator: Fernando Aguila, MD, Mount Carmel Health System

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2017
• Primary Completion (Actual): January 13, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: April 18, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (Actual): May 8, 2017

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Coffee Small Bowel

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual patient data at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No