The Effect of Coffee After Resection of Small Bowel

NCT03143621 | Completed

• 1 other identifier: Coffee Small Bowel
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Ileus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time to return of bowel function

  From date of hospital admission up to date of hospital discharge (anticipated up to 2 weeks)

• Length of Stay

  From date of hospital admission up to date of hospital discharge (anticipated up to 2 weeks)

Study Arms (2)

Coffee

EXPERIMENTAL

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

Dietary Supplement: Coffee

Water

PLACEBO COMPARATOR

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

Other: Water

Interventions

Coffee DIETARY_SUPPLEMENT

Brewed, caffeinated coffee, 100 cc's each dose

Coffee

Water OTHER

Tap water heated to same temperature as coffee

Water

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing small bowel resection. Can be elective, urgent or emergent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mount Carmel Health System: lead

Study Sites (1)

Mount Carmel Health System

Columbus, Ohio, 43213, United States

Location

MeSH Terms

Interventions

Coffee; Water

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Fernando Aguila, MD

  Mount Carmel Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, parallel-group, controlled clinical trial

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: May 8, 2017
• Study Start: November 15, 2017
• Primary Completion: January 13, 2022
• Study Completion: September 30, 2022
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)