Postoperative IleusCOFFEENCT02469441
Does Coffee Intake Reduce Postoperative Ileus After Elective Colorectal Surgery
An observational study of Postoperative Ileus, run by Kantonsspital Baden at 1 site in Switzerland.
Trial summary
The aim of the study is to investigate if postoperative coffee intake decreases the time until first bowel movement in elective colorectal surgery with primary anastomosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Ileus
- Type of treatment
- Injection or infusion
- How many people
- 136 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2014to 31 Dec 2016
- Phase
- Observational
- 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
Study population: Patients with elective colorectal surgery and primary anastomosis > 6cm above the anal verge without stoma formation
Who may be able to join
- Patients scheduled for elective laparoscopic or open colorectal surgery due to benign or malignant colorectal disease, which need a large bowel resection with primary anastomosis
- Age equal or greater than 18 years
- Patients that are able to give informed consent
- Elective Surgery
- Anastomosis above 6 cm from anal verge
Who cannot join
- Participation in other studies
- Additional small bowel anastomosis
- Need for extended adhesiolysis
- Need for a stoma (e.g. protective ileostomy)
- Emergency operation with diffuse peritonitis or preexisting ileus
- Preoperative radiation
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- Known hypersensitivity or allergy to coffee
- Expected lack of compliance
- Impaired mental state or language problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Coffee Intake Reduce Postoperative Ileus After Elective Colorectal Surgery - a Prospective, Randomized Controlled Study - the COFFEE STUDY
The aim of the study is to investigate if postoperative coffee intake decreases the time until first bowel movement in elective colorectal surgery with primary anastomosis.
Read the detailed description
Postoperative ileus after colorectal surgery is a frequent problem which significantly prolongs hospital stay and increases perioperative costs. Postoperative therapeutic interventions vary significantly between different hospitals due to missing evidence-based guidelines. Coffee is a safe, cheap and simple agent without significant side effects which can positively influence the bowel function.
The aim of the investigators is to evaluate in an own study if coffee consumption has an influence on the duration of postoperative ileus.
The present trial is designed to evaluate if postoperative coffee intake decreases the time until first bowel movement in colorectal surgery with primary anastomosis. This study would be the second study which evaluates the described questions under randomized conditions.
- Conditions
- Postoperative Ileus
- Keywords
- coffee, postoperative ileus, colorectal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Arm A (treatment arm: coffee): patients after colorectal surgery receive coffee in addition to the regular infusion therapy and/or alimentation | |
| Arm B | Arm B (control arm: water / tea): patients after colorectal surgery receive water or tea (excluding black tea) and no coffee until the first bowel movement in addition to the regular infusion therapy and/or alimentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first bowel movement
Time to first bowel movement (time from the end of surgery until the first passage of stool recorded by nursing staff) as a marker for the termination of postoperative ileus.
Measured: Follow-up per patient: 1 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study start1 Aug 2014
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
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 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Baden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gehrer Simone, Kantonsspital Baden
- Investigators
- Simone Hasler-Gehrer, MD, Principal investigator, Oberärztin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469441
- Sponsor's protocol ID
- 2014-062
- Acronym
- COFFEE
- Status last verified
- Jan 2017
- First submitted
- 29 May 2015
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hasler-Gehrer S, Linecker M, Keerl A, Slieker J, Descloux A, Rosenberg R, Seifert B, Nocito A. Does Coffee Intake Reduce Postoperative Ileus After Laparoscopic Elective Colorectal Surgery? A Prospective, Randomized Controlled Study: The Coffee Study. Dis Colon Rectum. 2019 Aug;62(8):997-1004. doi: 10.1097/DCR.0000000000001405.
PubMed 30998528
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Coffee Intake Reduce Postoperative Ileus After Elective Colorectal Surgery - a Prospective, Randomized Controlled Study - the COFFEE STUDY
- ClinicalTrials.gov ID
- NCT02469441
- Acronym / sponsor ID
- COFFEE / 2014-062
- Conditions
- Postoperative Ileus
- Keywords
- coffee, postoperative ileus, colorectal surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Kantonsspital BadenUniversity, hospital or other
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 11 Jun 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 aim of the study is to investigate if postoperative coffee intake decreases the time until first bowel movement in elective colorectal surgery with primary anastomosis.
Detailed description
Postoperative ileus after colorectal surgery is a frequent problem which significantly prolongs hospital stay and increases perioperative costs. Postoperative therapeutic interventions vary significantly between different hospitals due to missing evidence-based guidelines. Coffee is a safe, cheap and simple agent without significant side effects which can positively influence the bowel function.
The aim of the investigators is to evaluate in an own study if coffee consumption has an influence on the duration of postoperative ileus.
The present trial is designed to evaluate if postoperative coffee intake decreases the time until first bowel movement in colorectal surgery with primary anastomosis. This study would be the second study which evaluates the described questions under randomized conditions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | – | –Arm A (treatment arm: coffee): patients after colorectal surgery receive coffee in addition to the regular infusion therapy and/or alimentation |
| Arm B | – | –Arm B (control arm: water / tea): patients after colorectal surgery receive water or tea (excluding black tea) and no coffee until the first bowel movement in addition to the regular infusion therapy and/or alimentation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with elective colorectal surgery and primary anastomosis > 6cm above the anal verge without stoma formation
Key inclusion criteria (5 listed)
- Patients scheduled for elective laparoscopic or open colorectal surgery due to benign or malignant colorectal disease, which need a large bowel resection with primary anastomosis
- Age equal or greater than 18 years
- Patients that are able to give informed consent
- Elective Surgery
- Anastomosis above 6 cm from anal verge
Key exclusion criteria (9 listed)
- Participation in other studies
- Additional small bowel anastomosis
- Need for extended adhesiolysis
- Need for a stoma (e.g. protective ileostomy)
- Emergency operation with diffuse peritonitis or preexisting ileus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to first bowel movement
Time frame: Follow-up per patient: 1 month postoperatively
Time to first bowel movement (time from the end of surgery until the first passage of stool recorded by nursing staff) as a marker for the termination of postoperative ileus.
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 20 Jan 2017.
- Derived from this study: PubMed 30998528Hasler-Gehrer S, Linecker M, Keerl A, Slieker J, Descloux A, Rosenberg R, Seifert B, Nocito A. Does Coffee Intake Reduce Postoperative Ileus After Laparoscopic Elective Colorectal Surgery? A Prospective, Randomized Controlled Study: The Coffee Study. Dis Colon Rectum. 2019 Aug;62(8):997-1004. doi: 10.1097/DCR.0000000000001405.
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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.
Simone Hasler-Gehrer, MD principal investigator
Oberärztin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Ileus, run by Kantonsspital Baden at 1 site in Switzerland.
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 5 inclusion and 9 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 20 Jan 2017. 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 Switzerland. 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?
Time to first bowel movement (time frame: Follow-up per patient: 1 month postoperatively). 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 NCT02469441, 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 20 Jan 2017.