Postoperative IleusNCT02639728
The Effect of Coffee Consumption in Enhancing Recovery of Bowel Function Following Colorectal Surgery.
A study testing Regular Coffee, Decaffeinated coffee and Warm water in people with Postoperative Ileus, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The effects of coffee have been shown to act as a colonic stimulant. Caffeinated coffee stimulates colonic activity, most notably in the transverse/descending colon, in magnitude similar to a meal, 60% stronger than water, and 23% stronger than decaffeinated coffee. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- Regular Coffee, Decaffeinated coffee and Warm water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to 23 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients due to undergo small and/or large partial bowel resection via laparotomy or laparoscopy with primary anastomosis. Planned postoperative care includes removing the NG tube at the end of surgery and clear liquid diet of POD #1.
- Patients, both male and female, must be between the ages of 18-85.
- Patients must be able to freely give written informed consent to participate in the study and have signed the Informed Consent Form.
Who cannot join
- • Study patients who do not meet inclusion criteria will not qualify for study inclusion.
- Patients with a history of prior intestinal surgery, excluding appendectomy.
- Patients who require an ostomy during their elective colorectal surgery.
- Patients who require postoperative ventilation, pressors, or ICU stay.
- Those who are mentally incompetent, unable, or unwilling to provide informed consent or comply with study procedures.
- American Society of Anesthesiologist (ASA) class IV or V.
Show all 14Show fewer
- Those with a history of carcinomatosis.
- Those with a history of radiation enteritis.
- Women who are pregnant.
- Patients who have a history of epilepsy.
- Patients with prior cardiovascular disorders including uncontrolled hypertension, prior myocardial infarction, or heart failure.
- Patients with peptic ulcers.
- Patients with glaucoma.
- Non-English Speakers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of the Effect of Coffee Consumption in Enhancing Recovery of Bowel Function Following Colorectal Surgery.
The effects of coffee have been shown to act as a colonic stimulant. Caffeinated coffee stimulates colonic activity, most notably in the transverse/descending colon, in magnitude similar to a meal, 60% stronger than water, and 23% stronger than decaffeinated coffee. [1] Moreover, the consumption of both water and caffeine causes a decrease in the rectal sensory threshold for the desire to defecate, while anal sphincter pressure after caffeine intake is significantly higher than after water intake. This may result in an earlier desire to defecate. [2] Coffee has also been shown to have an effect on defecation by increasing rectal tone by 45% (measured with a barostat) thirty minutes after consumption. [3]
Read the detailed description
Study Objectives
Primary objective: To determine if the use of coffee in the postoperative period will reduce time to recovery of GI function by at least one day in patients undergoing elective colorectal operations. (This will be assessed by twice daily interview of patients as to whether they have passed flatus or had a bowel movement)
Secondary objective: To determine if the use of coffee in the postoperative period will reduce hospital length of stay by at least one day, and to also evaluate the tolerance of solid food, which will help determine postoperative ileus and rates of vomiting/nasogastric tube (re)insertion, and other perioperative morbidities such as anastomotic leak, wound infection, and intra-abdominal abscesses in patients undergoing elective colorectal operations.
Study Design
This study involves the evaluation of patients who consume coffee compared with patients who consume warm water during the postoperative period after elective colorectal surgery with primary anastomosis.
This study will be a single-center, randomized trial. Patients who undergo elective colorectal surgery at Cedars-Sinai Medical Center and agree to participate in the study will be randomized 1:1:1 to those who drink regular coffee, decaffeinated coffee, and no coffee. Randomization will occur via an online program (www.randomizer.org), which assigns participants to experimental conditions. The subjects assigned to drink regular coffee, decaffeinated coffee, or warm water will be given a 4oz cup three times daily and will be instructed to consume all of its liquid contents.
Postoperative care will otherwise be the same for all subjects, as dictated by the clinical judgment of the surgical team.
- Conditions
- Postoperative Ileus
- Being tested
- Regular Coffee, Decaffeinated coffee, Warm water
- Keywords
- Bowel surgery, Postoperative bowel recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular CoffeeOther
Regular coffee will be given a 4oz cup three times daily and will be instructed to consume all of its liquid contents.
Decaffeinated coffeeOther
Decaffeinated coffee will be given a 4oz cup three times daily and will be instructed to consume all of its liquid contents.
Warm waterOther
Warm water will be given a 4oz cup three times daily and will be instructed to consume all of its liquid contents.
| Study group | Role | What they receive |
|---|---|---|
| Regular coffee | Experimental | Will receive a 4oz cup coffee, three times daily (at 8:00, 12:00, and 16:00 hours)and instructed to consume the entirety of its liquid contents. This liquid consumption will begin on the morning of POD #1 at 8:00 hours. Duration of experimental treatment will last until first flatus or bowel movement or 7 days, whichever comes first. Receives: Other: Regular Coffee |
| Decaffeinated coffee | Experimental | Will receive a 4oz cup of decaffeinated coffee (at 8:00, 12:00, and 16:00 hours) and instructed to consume the entirety of its liquid contents. This liquid consumption will begin on the morning of POD #1 at 8:00 hours. Duration of experimental treatment will last until first flatus or bowel movement or 7 days, whichever comes first. Receives: Other: Decaffeinated coffee |
| Warm water | Experimental | Will receive a 4oz cup of warm water at 8:00, 12:00, and 16:00 hours) and instructed to consume the entirety of its liquid contents. This liquid consumption will begin on the morning of POD #1 at 8:00 hours. Duration of experimental treatment will last until first flatus or bowel movement or 7 days, whichever comes first. Receives: Other: Warm water |
What is being measured
The primary outcome is the main question the study is designed to answer.
GI Function
Time to first flatus and/or bowel movement as assessed twice per day by inquiry from the primary team and study investigators.
Measured: 30 days
Secondary outcomes (6)
Hospital Days
Evaluation of length of postoperative hospital stay, will be recorded from medical records.
Measured: 30 days
Vomiting
Evaluation of number of episodes of vomiting will be collected from medical records
Measured: 30 days
Nasogastric tube
Number of nasogastric tube (re)insertion, will be collected from medical records
Measured: 30 days
Anastomotic leak
Evaluation of any anastomotic leak will be collected from medical records
Measured: 30 days
Wound Infection
Evaluation for any wound infection will be collected from medical records
Measured: 30 days
Abscesses
Evaluation for any intra-abdominal abscess will be collected from medical records
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2015 (estimated)
- Study startNov 2013
- Primary completion23 Mar 2022
- Study completion23 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yosef Nasseri, MD, Cedars-Sinai Medical Center
- Investigators
- Yosef Nasseri, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639728
- Sponsor's protocol ID
- Pro00030891
- Status last verified
- Nov 2022
- First submitted
- 10 Dec 2015
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Rao SS, Welcher K, Zimmerman B, Stumbo P. Is coffee a colonic stimulant? Eur J Gastroenterol Hepatol. 1998 Feb;10(2):113-8. doi: 10.1097/00042737-199802000-00003.
PubMed 9581985Lohsiriwat S, Kongmuang P, Leelakusolvong S. Effects of caffeine on anorectal manometric findings. Dis Colon Rectum. 2008 Jun;51(6):928-31. doi: 10.1007/s10350-008-9271-y. Epub 2008 Mar 19.
PubMed 18350336Sloots CE, Felt-Bersma RJ, West RL, Kuipers EJ. Stimulation of defecation: effects of coffee use and nicotine on rectal tone and visceral sensitivity. Scand J Gastroenterol. 2005 Jul;40(7):808-13. doi: 10.1080/00365520510015872.
PubMed 16109656Muller SA, Rahbari NN, Schneider F, Warschkow R, Simon T, von Frankenberg M, Bork U, Weitz J, Schmied BM, Buchler MW. Randomized clinical trial on the effect of coffee on postoperative ileus following elective colectomy. Br J Surg. 2012 Nov;99(11):1530-8. doi: 10.1002/bjs.8885. Epub 2012 Sep 14.
PubMed 22987303Nasseri Y, Kasheri E, Oka K, Zhu R, Smiley A, Cohen J, Ellenhorn J, Barnajian M. Does coffee affect bowel recovery following minimally invasive colorectal operations? A three-armed randomized controlled trial. Int J Colorectal Dis. 2023 Jul 20;38(1):199. doi: 10.1007/s00384-023-04494-7.
PubMed 37470901
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of the Effect of Coffee Consumption in Enhancing Recovery of Bowel Function Following Colorectal Surgery.
- ClinicalTrials.gov ID
- NCT02639728
- Acronym / sponsor ID
- Pro00030891
- Conditions
- Postoperative Ileus
- Keywords
- Bowel surgery, Postoperative bowel recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- 23 Mar 2022 (actual)
- Study completion
- 23 Mar 2022 (actual)
- First posted
- 24 Dec 2015 (estimated)
- 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.
The effects of coffee have been shown to act as a colonic stimulant. Caffeinated coffee stimulates colonic activity, most notably in the transverse/descending colon, in magnitude similar to a meal, 60% stronger than water, and 23% stronger than decaffeinated coffee. [1] Moreover, the consumption of both water and caffeine causes a decrease in the rectal sensory threshold for the desire to defecate, while anal sphincter pressure after caffeine intake is significantly higher than after water intake. This may result in an earlier desire to defecate. [2] Coffee has also been shown to have an effect on defecation by increasing rectal tone by 45% (measured with a barostat) thirty minutes after consumption. [3]
Detailed description
Study Objectives
Primary objective: To determine if the use of coffee in the postoperative period will reduce time to recovery of GI function by at least one day in patients undergoing elective colorectal operations. (This will be assessed by twice daily interview of patients as to whether they have passed flatus or had a bowel movement)
Secondary objective: To determine if the use of coffee in the postoperative period will reduce hospital length of stay by at least one day, and to also evaluate the tolerance of solid food, which will help determine postoperative ileus and rates of vomiting/nasogastric tube (re)insertion, and other perioperative morbidities such as anastomotic leak, wound infection, and intra-abdominal abscesses in patients undergoing elective colorectal operations.
Study Design
This study involves the evaluation of patients who consume coffee compared with patients who consume warm water during the postoperative period after elective colorectal surgery with primary anastomosis.
This study will be a single-center, randomized trial. Patients who undergo elective colorectal surgery at Cedars-Sinai Medical Center and agree to participate in the study will be randomized 1:1:1 to those who drink regular coffee, decaffeinated coffee, and no coffee. Randomization will occur via an online program (www.randomizer.org), which assigns participants to experimental conditions. The subjects assigned to drink regular coffee, decaffeinated coffee, or warm water will be given a 4oz cup three times daily and will be instructed to consume all of its liquid contents.
Postoperative care will otherwise be the same for all subjects, as dictated by the clinical judgment of the surgical team.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Regular coffee | Experimental | Other: Regular CoffeeWill receive a 4oz cup coffee, three times daily (at 8:00, 12:00, and 16:00 hours)and instructed to consume the entirety of its liquid contents. This liquid consumption will begin on the morning of POD #1 at 8:00 hours. Duration of experimental treatment will last until first flatus or bowel movement or 7 days, whichever comes first. |
| Decaffeinated coffee | Experimental | Other: Decaffeinated coffeeWill receive a 4oz cup of decaffeinated coffee (at 8:00, 12:00, and 16:00 hours) and instructed to consume the entirety of its liquid contents. This liquid consumption will begin on the morning of POD #1 at 8:00 hours. Duration of experimental treatment will last until first flatus or bowel movement or 7 days, whichever comes first. |
| Warm water | Experimental | Other: Warm waterWill receive a 4oz cup of warm water at 8:00, 12:00, and 16:00 hours) and instructed to consume the entirety of its liquid contents. This liquid consumption will begin on the morning of POD #1 at 8:00 hours. Duration of experimental treatment will last until first flatus or bowel movement or 7 days, whichever comes first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Patients due to undergo small and/or large partial bowel resection via laparotomy or laparoscopy with primary anastomosis. Planned postoperative care includes removing the NG tube at the end of surgery and clear liquid diet of POD #1.
Key exclusion criteria (14 listed)
- • Study patients who do not meet inclusion criteria will not qualify for study inclusion.
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 |
|---|---|---|
| Regular CoffeeRegular coffee will be given a 4oz cup three times daily and will be instructed to consume all of its liquid contents. | Other | Regular coffee |
| Decaffeinated coffeeDecaffeinated coffee will be given a 4oz cup three times daily and will be instructed to consume all of its liquid contents. | Other | Decaffeinated coffee |
| Warm waterWarm water will be given a 4oz cup three times daily and will be instructed to consume all of its liquid contents. | Other | Warm water |
Primary outcome
GI Function
Time frame: 30 days
Time to first flatus and/or bowel movement as assessed twice per day by inquiry from the primary team and study investigators.
6 secondary outcomes
Hospital Days
Time frame: 30 days
Vomiting
Time frame: 30 days
Nasogastric tube
Time frame: 30 days
Anastomotic leak
Time frame: 30 days
Wound Infection
Time frame: 30 days
Abscesses
Time frame: 30 days
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 21 Nov 2022.
- Background: PubMed 9581985Rao SS, Welcher K, Zimmerman B, Stumbo P. Is coffee a colonic stimulant? Eur J Gastroenterol Hepatol. 1998 Feb;10(2):113-8. doi: 10.1097/00042737-199802000-00003.
- Background: PubMed 18350336Lohsiriwat S, Kongmuang P, Leelakusolvong S. Effects of caffeine on anorectal manometric findings. Dis Colon Rectum. 2008 Jun;51(6):928-31. doi: 10.1007/s10350-008-9271-y. Epub 2008 Mar 19.
- Background: PubMed 16109656Sloots CE, Felt-Bersma RJ, West RL, Kuipers EJ. Stimulation of defecation: effects of coffee use and nicotine on rectal tone and visceral sensitivity. Scand J Gastroenterol. 2005 Jul;40(7):808-13. doi: 10.1080/00365520510015872.
- Background: PubMed 22987303Muller SA, Rahbari NN, Schneider F, Warschkow R, Simon T, von Frankenberg M, Bork U, Weitz J, Schmied BM, Buchler MW. Randomized clinical trial on the effect of coffee on postoperative ileus following elective colectomy. Br J Surg. 2012 Nov;99(11):1530-8. doi: 10.1002/bjs.8885. Epub 2012 Sep 14.
- Derived from this study: PubMed 37470901Nasseri Y, Kasheri E, Oka K, Zhu R, Smiley A, Cohen J, Ellenhorn J, Barnajian M. Does coffee affect bowel recovery following minimally invasive colorectal operations? A three-armed randomized controlled trial. Int J Colorectal Dis. 2023 Jul 20;38(1):199. doi: 10.1007/s00384-023-04494-7.
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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.
Yosef Nasseri, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular Coffee, Decaffeinated coffee and Warm water in people with Postoperative Ileus, run by Cedars-Sinai Medical Center 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 3 inclusion and 14 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 21 Nov 2022. 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. 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?
GI Function (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02639728, which also lists 5 linked publications.
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 21 Nov 2022.