Improving consumption compliance and satisfaction with quality coffee to enhance bowel recovery after colorectal surgery
| ISRCTN | ISRCTN97926586 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97926586 |
- Submission date
- 07/05/2024
- Registration date
- 08/05/2024
- Last edited
- 28/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Colorectal surgery is frequently followed by a prolonged absence of bowel function called post-operative ileus (POI). Recent studies have shown that coffee consumption after surgery leads to a faster recovery of bowel function. However, such a protocol with coffee served at the hospital is not always the most pleasant experience and compliance is unknown. This study looks at issues that are key to ensuring widespread implementation and routine use of a standardized coffee for POI prevention, such as choosing a freshly made quality coffee “at the patient’s bedside”, according to personal preference (flavour and amount). This study aims to measure patients’ compliance and satisfaction with tasty, freshly made and high-quality coffee made using a capsule system to enhance compliance for POI prevention after colorectal surgery.
Who can participate?
Patients aged 18 years old and over who are scheduled for elective colorectal surgery or stony closure in our hospital
What does the study involve?
The study involves drinking 3 coffees per day. The participant can choose among a selection of 4 different types of coffee ensuring a variety of flavours to satisfy different tastes and add a ludic dimension. The participant is asked to complete a diary about consumption and satisfaction with the experiment.
What are the possible benefits and risks of participating?
The participant will benefit from the effect and the satisfaction of freshly brewed coffee, with no specific risk.
Where is the study run from?
January 2021 to October 2022
When is the study starting and how long is it expected to run for?
The visceral surgery service at Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, Switzerland
Who is funding the study?
Nestlé Health Science
Who is the main contact?
Constant Delabays, constant.delabays@chuv.ch
Contact information
Public, Scientific
Rue du Bugnon 46
Lausanne
1011
Switzerland
 ORCID ID |
0000-0002-9346-9486 |
|---|---|
| Phone | +41799546922 |
| constant.delabays@chuv.ch |
Principal Investigator
Rue du Bugnon 46
Lausanne
1011
Switzerland
| ORCID ID |
0000-0002-4521-8279 |
|---|---|
| Phone | +41 079 556 15 06 |
| Martin.Hubner@chuv.ch |
Public
Rue du Bugnon 46
Lausanne
1011
Switzerland
| Phone | +41799546922 |
|---|---|
| delabays.constant@gmail.com |
Study information
| Study design | Prospective monocentric single-arm feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Improving compliance and satisfaction with quality coffee in-take to enhance bowel recovery after colorectal surgery |
| Study acronym | Coffee trial |
| Study objectives | The key to ensure widespread implementation and routine use of a standardized coffee for post operative ileus prevention is to choose a freshly made quality coffee “at the patient’s bedside”, according to personal preference (flavour and amount). |
| Ethics approval(s) |
Approved 07/09/2021, CER VD (Avenue de Chailly 23, Lausanne, 1012, Switzerland; +41 21 316 18 30; secretariat.CER@vd.ch), ref: CER-VD 2021-01430 |
| Health condition(s) or problem(s) studied | Compliance to coffee in the post operative setting after elective colorectal surgery or ostomy closure |
| Intervention | Daily doses of freshly made coffee with a capsule coffee system will be proposed and served to participants 3 times a day, starting from the first day after surgery, for a total of 3 days. This protocol and schedule are based on studies demonstrating the effectiveness of coffee intake in POI prevention. Doses are scheduled on a standard basis (8:00 a.m., 12:00 p.m. and 3:00 p.m.) but remain flexible and can be adapted according to the wishes of each patient. Participants will also be able to use the coffee machine themselves, thus stimulating early mobilization. A selection of different types of coffee is also proposed, ensuring a variety of flavours to satisfy every participant’s taste and add a ludic dimension. In addition, the coffee will be offered in two ways: Espresso (40 ml) or Lungo (110 ml), at the patient’s discretion. The dose of caffeine is standardized and equal in each capsule, varying between 60 and 80 mg depending on the type and variety of coffee. Finally, to guarantee an optimal sensory and visual experience, the coffee will be offered in glass cups. The day before surgery, participants will receive a diary to self-assess postoperative compliance to the suggested schedule, resp. its reasons and reasons for non-compliance. After every coffee proposal, compliance and/or reason for non-compliance will be reported by the patient and controlled by nurses. At the end of the 9 doses planned by the study, a survey will be conducted to evaluate the experience and satisfaction of each participant (patient-related experience measure PREM). Secondary outcomes such as time to first transit, complication and length of hospital stay are systematically assessed in a prospective enhanced recovery (ERAS) database and will be extracted for this study. Post-operative surveillance and care will not deviate from the standard protocol for colorectal procedures in the Department of Visceral Surgery. These consist of standardized postoperative controls (dedicated care maps and clinical itineraries). There is no exclusion criterion for patients after enrolment. No material will be sampled for this study and no particular biases are expected. |
| Intervention type | Supplement |
| Primary outcome measure | 1. Compliance with coffee measured using a capsule system at the suggested schedule using a self-report diary during the three first postoperative days (ie a total of 9 possible coffees) 2. Reason for non-compliance to coffee measured using a self-report diary during the first three days |
| Secondary outcome measures | 1. Satisfaction and the experience felt by each participant measured using a specific and dedicated Patient-Related Experience Measure (PREM) questionnaire after 3 postoperative days 2. Bowel recovery (time to first flatus and first bowel movement), measured using data documented by a nurse during hospitalisation 3. Length of hospital stay (interval from the day of operation until the day of discharge) measured using medical records at the end of the study 4. Post-operative 30-day complication measured using the Dindo-Clavien classification during hospitalisation and 30 days follow-up |
| Overall study start date | 15/01/2021 |
| Completion date | 31/10/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 53 |
| Key inclusion criteria | Scheduled for elective colorectal surgery or stony closure in our hospital |
| Key exclusion criteria | 1. Impaired cognitive status 2. Intolerance to coffee 3. Pregnancy 4. Pre-existing ileus 5. Need for post-operative surveillance in intensive or intermediate care units |
| Date of first enrolment | 01/11/2021 |
| Date of final enrolment | 31/08/2022 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Lausanne
1011
Switzerland
Sponsor information
Hospital/treatment centre
Rue du Bugnon 46
Lausanne
1011
Switzerland
| Phone | +41 21 314 24 00 |
|---|---|
| Demartines@chuv.ch | |
| Website | https://www.chuv.ch/fr/chuv-home/ |
"ROR" |
https://ror.org/05a353079 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Nestlé Health Science S.A.
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The Datasets generated during and/or analyses during the current study will be available upon request from Constant Delabays, constant.delabays@chuv.ch |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 28/11/2024 | No | No |
Additional files
Editorial Notes
28/11/2024: Basic results uploaded.
07/05/2024: Study's existence confirmed by the Cantonal Commission for Ethics in Research on Human Beings.
