Postoperative IleusNCT03143621
The Effect of Coffee After Resection of Small Bowel
A study testing Coffee and Water in people with Postoperative Ileus, run by Mount Carmel Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- Coffee and Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2017to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing small bowel resection. Can be elective, urgent or emergent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Coffee Consumption on Return to Bowel Function After Small Bowel Resection
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
- Being tested
- Coffee, Water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoffeeDietary supplement
Brewed, caffeinated coffee, 100 cc's each dose
WaterOther
Tap water heated to same temperature as coffee
| Study group | Role | What they receive |
|---|---|---|
| Coffee | Experimental | 100 cc's of coffee administered three times per day until return to bowel function has been established. Receives: 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. Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to removal of nasogastric tube
Time at placement to Time at removal through study completion
Measured: 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
Time from end of surgery to Time of first flatus or bowel movement through study completion
Measured: 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
Measured: From date of hospital admission up to date of hospital discharge (anticipated up to 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start15 Nov 2017
- Primary completion13 Jan 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel-group, controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Carmel Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernando Aguila, MD, Principal investigator, Mount Carmel Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143621
- Sponsor's protocol ID
- Coffee Small Bowel
- Status last verified
- Aug 2023
- First submitted
- 18 Apr 2017
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual patient data at this time.
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Coffee Consumption on Return to Bowel Function After Small Bowel Resection
- ClinicalTrials.gov ID
- NCT03143621
- Acronym / sponsor ID
- Coffee Small Bowel
- Conditions
- Postoperative Ileus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Mount Carmel Health SystemUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 13 Jan 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, parallel-group, controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Coffee | Experimental | Dietary Supplement: Coffee100 cc's of coffee administered three times per day until return to bowel function has been established. |
| Water | Placebo comparator | Other: Water100 cc's of warm water administered three times per day until return to bowel function has been established. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing small bowel resection. Can be elective, urgent or emergent.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoffeeBrewed, caffeinated coffee, 100 cc's each dose | Dietary supplement | Coffee |
| WaterTap water heated to same temperature as coffee | Other | Water |
Primary outcome
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
2 secondary outcomes
Time to return of bowel function
Time frame: From date of hospital admission up to date of hospital discharge (anticipated up to 2 weeks)
Length of Stay
Time frame: From date of hospital admission up to date of hospital discharge (anticipated up to 2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Individual participant dataSharing planned: No. There is no plan to share individual patient data at this time.
Related trials for Postoperative Ileus
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Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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At-Home Bowel Stimulation
Post-Operative Ileus (POI)
Recruiting
The Food Network Effect
Post Operative Patients
RecruitingPhase 4
Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery
Pain, Postoperative, Postoperative Ileus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Aguila, MD principal investigator
Mount Carmel Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coffee and Water in people with Postoperative Ileus, run by Mount Carmel Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to removal of nasogastric tube (time frame: From date of hospital admission up to date of hospital discharge (anticipated up to 2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.