The Effect of Coffee After Resection of Small Bowel

Sponsor

Mount Carmel Health System (Other)

Overall Status

Recruiting

CT.gov ID

NCT03143621

Collaborator

(none)

120

Enrollment

Location

Arms

61.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Ileus	Dietary Supplement: Coffee Other: Water	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, parallel-group, controlled clinical trialRandomized, parallel-group, controlled clinical trial

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Patients will not be told what group they are assigned to, however, complete masking will be difficult to achieve. The patient's treatment assignment is part of the medical record.

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Nov 15, 2017

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mount Carmel Health System	Columbus	Ohio	United States	43213

Sponsors and Collaborators

Mount Carmel Health System

Investigators

Principal Investigator: Fernando Aguila, MD, Mount Carmel Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mount Carmel Health System

ClinicalTrials.gov Identifier:

NCT03143621

Other Study ID Numbers:

Coffee Small Bowel

First Posted:

May 8, 2017

Last Update Posted:

Feb 11, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 11, 2022