The Effect of Coffee After Resection of Small Bowel

Study Overview
=================
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.

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

Conditions
-----------------
Postoperative Ileus

Intervention / Treatment
-----------------
* Dietary Supplement: Coffee
* Other: Water


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, parallel-group, controlled clinical trial
Masking: Double


Arms and Interventions

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

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) |