ColectomyNCT01079442
Coffee Trial - Does Coffee Intake Reduce Postoperative Ileus After Elective Colectomy?
A study testing Postoperative coffee and water in people with Colectomy, run by Heidelberg University at 3 sites in Germany.
Trial summary
The purpose of the investigators study is to investigate the effects of coffee on the return of bowel function and appetite, length of hospital stay, and complications after elective open colectomy in a prospective randomized trial. The primary efficacy endpoint is time to first bowel movement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colectomy
- What is being tested?
- Postoperative coffee and water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 3 sitesGermany
- Study dates
- Mar 2010to Mar 2011
- 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 scheduled for elective open or laparoscopic colectomy
- Age equal or greater than 18 years
- Informed consent
Who cannot join
- Participation in concurrent intervention trials
- Need for a stoma
- Known hypersensitivity or allergy to coffee
- Expected lack of compliance
- Impaired mental state or language problems
- change in surgical procedure
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Salem Krankenhaus
Heidelberg, 69120
University hospital
Heidelberg, 69120
Kreiskrankenhaus GRN Sinsheim
Sinsheim
About this study
Official title: Does Coffee Intake Reduce Postoperative Ileus After Elective Colectomy?
The purpose of the investigators study is to investigate the effects of coffee on the return of bowel function and appetite, length of hospital stay, and complications after elective open colectomy in a prospective randomized trial. The primary efficacy endpoint is time to first bowel movement.
Read the detailed description
Coffee is a popular beverage. Its effects on general well being, central nervous system and cardiovascular system are well known, but there is limited information regarding its effects on gastrointestinal function.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative coffeeOther
Also called Lavazza Blue Espresso Dolce 100% Arabica coffee
schedule for coffee administration for the present trial was chosen as follows (starting 6 hours postoperatively):
- 08:00 100mL beverage
- 12:00 100mL beverage
- 16:00 100mL beverage
waterOther
Also called tap water
The control drink consists of 100 ml warm water which is administered according a same fixed schedule as Group A starting 6 hours postoperatively:
- 08:00 100mL beverage
- 12:00 100mL beverage
- 16:00 100mL beverage
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm: coffee | Active comparator | coffee administration Receives: Other: Postoperative coffee |
| Water arm | Placebo comparator | The control drink consists of 100 ml warm water Receives: Other: water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first bowel movement
Time from end of surgery until patient's first bowel movement (i.e. passage of stool).
Measured: patients postoperative in hospital stay (mean 6 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ColectomyStudies 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
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuh Rahbari, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079442
- Sponsor's protocol ID
- NNR-6
- Status last verified
- Sep 2011
- First submitted
- 1 Mar 2010
- Last updated
- 30 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Muller 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 22987303
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Coffee Intake Reduce Postoperative Ileus After Elective Colectomy?
- ClinicalTrials.gov ID
- NCT01079442
- Acronym / sponsor ID
- NNR-6
- Conditions
- Colectomy
- Keywords
- postoperative ileus after colonic resections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 3 Mar 2010 (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 purpose of the investigators study is to investigate the effects of coffee on the return of bowel function and appetite, length of hospital stay, and complications after elective open colectomy in a prospective randomized trial. The primary efficacy endpoint is time to first bowel movement.
Detailed description
Coffee is a popular beverage. Its effects on general well being, central nervous system and cardiovascular system are well known, but there is limited information regarding its effects on gastrointestinal function.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm: coffee | Active comparator | Other: Postoperative coffeecoffee administration |
| Water arm | Placebo comparator | Other: waterThe control drink consists of 100 ml warm water |
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 scheduled for elective open or laparoscopic colectomy
- Age equal or greater than 18 years
- Informed consent
Key exclusion criteria (6 listed)
- Participation in concurrent intervention trials
- Need for a stoma
- Known hypersensitivity or allergy to coffee
- Expected lack of compliance
- Impaired mental state or language problems
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 |
|---|---|---|
| Postoperative coffeeAlso: Lavazza Blue Espresso Dolce 100% Arabica coffeeschedule for coffee administration for the present trial was chosen as follows (starting 6 hours postoperatively): * 08:00 100mL beverage * 12:00 100mL beverage * 16:00 100mL beverage | Other | Treatment arm: coffee |
| waterAlso: tap waterThe control drink consists of 100 ml warm water which is administered according a same fixed schedule as Group A starting 6 hours postoperatively: * 08:00 100mL beverage * 12:00 100mL beverage * 16:00 100mL beverage | Other | Water arm |
Primary outcome
Time to first bowel movement
Time frame: patients postoperative in hospital stay (mean 6 days)
Time from end of surgery until patient's first bowel movement (i.e. passage of stool).
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 30 Sep 2011.
- Derived from this study: 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative coffee and water in people with Colectomy, run by Heidelberg University at 3 sites in Germany.
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 6 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 30 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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 first bowel movement (time frame: patients postoperative in hospital stay (mean 6 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 NCT01079442, which also lists 1 linked publication.
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 30 Sep 2011.