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NCT Number: NCT03143621

The Effect of Coffee After Resection of Small Bowel

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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Key information

Conditions

Postoperative Ileus

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Carmel Health System

Columbus, Ohio, 43213, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Coffee

Dietary Supplement

Brewed, caffeinated coffee, 100 cc's each dose

Water

Other

Tap water heated to same temperature as coffee

Primary outcomes

  1. Time to removal of nasogastric tube

    Time frame: 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 outcomes

  1. Time to return of bowel function

    Time frame: 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

  2. Length of Stay

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mount Carmel Health System

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
May 8, 2017
Registry last updated
Aug 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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