The Effect of Coffee After Resection of Small Bowel

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-15

Study Completion Date

2022-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Postoperative Ileus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, parallel-group, controlled clinical trial

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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Coffee

100 cc's of coffee administered three times per day until return to bowel function has been established.

Group Type EXPERIMENTAL

Coffee

Intervention Type DIETARY_SUPPLEMENT

Brewed, caffeinated coffee, 100 cc's each dose

Water

100 cc's of warm water administered three times per day until return to bowel function has been established.

Group Type PLACEBO_COMPARATOR

Water

Intervention Type OTHER

Tap water heated to same temperature as coffee

Interventions

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Coffee

Brewed, caffeinated coffee, 100 cc's each dose

Intervention Type DIETARY_SUPPLEMENT

Water

Tap water heated to same temperature as coffee

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No