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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coffee | Experimental | 100 cc's of coffee administered three times per day until return to bowel function has been established. |
|
| Water | Placebo Comparator | 100 cc's of warm water administered three times per day until return to bowel function has been established. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coffee | Dietary Supplement | Brewed, caffeinated coffee, 100 cc's each dose |
| |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Aguila, MD | Mount Carmel Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Carmel Health System | Columbus | Ohio | 43213 | United States |
There is no plan to share individual patient data at this time.
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| ID | Term |
|---|---|
| D003069 | Coffee |
| D014867 | Water |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
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Randomized, parallel-group, controlled clinical trial
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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.
| Water |
| Other |
Tap water heated to same temperature as coffee |
|
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) |
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |