Colorectal CancerNCT02422680
Patient Satisfaction With Colonoscopy in a Danish Setting - What Are the Most Important Factors?
An observational study of Colorectal Cancer, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
The study aim is to investigate factors associated with patient satisfaction during a colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Mar 2015to 31 Dec 2019
- How long will I take part?
- 1 Day
- 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 referred to colonoscopy at the out patient clinic at Aalborg University department. All patients deemed fit to for at colonoscopy at the outpaient clinic were included. The patient population is a mix of screening and non-screening patients. The study begins in april 2015.
Who may be able to join
- All patients referred to colonoscopy at the out-patient clinic at Aalborg University department.
Who cannot join
- Rejection to fill out questionaire.
- Patents referred to AVA (advanced endoscopy unit) were excluded as the are not comparable to regular colonoscopies. Most patients are referred to AVA for specific endoscopy treatments such as large polyp removals etc.
Trial locations and contacts
1 site in 1 country.
About this study
The study aim is to investigate factors associated with patient satisfaction during a colonoscopy.
Read the detailed description
The study aim to capture key quality indicators and patient satisfaction for 800 patients referred for a colonoscopy at Aalborg University Hospital. The patient population is mix of screening and non-screening colonoscopies seen at our out-patient clinic.
Each Colonoscopy is registered using a specially designed registration form and a more detailed form relating to the colonoscopy itself. The data collected includes: The Colonoscopist endoscopy experience and education, Medicine use, Colonoscopy duration, Unadjusted Caecum Intubations rate, Polyp detection rate, Polyps removed, Cancer detection rate and Nurse assisted Gloucester Comfort score.
Patient level data were recorded using a questionaire with 6 questions regarding satisfaction, pain, discomfort etc on a 10 cm analog scale.
- Conditions
- Colorectal Cancer
- Being tested
- No intervention, purely observational.
- Keywords
- Quality assurance, Caecum intubation rate, Patient satisfaction
- Medical subject headings
- Colorectal Neoplasms, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, purely observational.Procedure or surgery
No intervention is made other than following existing guidelines for colonoscopy. Further treatment and/or renewed colonoscopy in case of positive findings follows existing guidelines. The group is used only used to collect quality assurance data.
| Study group | Role | What they receive |
|---|---|---|
| Patients referred to a colonoscopy | A min. of 800 patients referred to colonoscopy at Aalborg University Hospital. The 800 patients are from the out patient clinic. A mix of screening and non-screening patients. Receives: Procedure: No intervention, purely observational. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Each patient were given a questionaire with 6 questions answering satisfaction, pain, discomfort etc on a 10 cm analog scale.
Measured: 1 day
Secondary outcomes (2)
Nurses perception of patients' pain
Nurse assisted Gloucester Comfort score
Measured: 1 day
Patient Pain (own Perception)
10 cm analog scale
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study start23 Mar 2015
- Primary completion30 Sep 2015
- Study completion31 Dec 2019 (estimated)
Why it stopped: Cancelled according to PhD-protocol with insufficient time to complete the study
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 Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nordsim
- Responsible party
- Principal investigator, Lasse Pedersen, Aalborg University Hospital
- Investigators
- Lasse Pedersen, m.d., Principal investigator, Aalborg University Hospital, Surgical Department.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422680
- Sponsor's protocol ID
- AalborgH
- Status last verified
- Jul 2019
- First submitted
- 10 Apr 2015
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Chartier L, Arthurs E, Sewitch MJ. Patient satisfaction with colonoscopy: a literature review and pilot study. Can J Gastroenterol. 2009 Mar;23(3):203-9. doi: 10.1155/2009/903545.
PubMed 19319384
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction With Colonoscopy in a Danish Setting - What Are the Most Important Factors?
- ClinicalTrials.gov ID
- NCT02422680
- Acronym / sponsor ID
- AalborgH
- Conditions
- Colorectal Cancer
- Keywords
- Quality assurance, Caecum intubation rate, Patient satisfaction
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Cancelled according to PhD-protocol with insufficient time to complete the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Nordsim
- Study start
- 23 Mar 2015 (actual)
- Primary completion
- 30 Sep 2015 (actual)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 21 Apr 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 study aim is to investigate factors associated with patient satisfaction during a colonoscopy.
Detailed description
The study aim to capture key quality indicators and patient satisfaction for 800 patients referred for a colonoscopy at Aalborg University Hospital. The patient population is mix of screening and non-screening colonoscopies seen at our out-patient clinic.
Each Colonoscopy is registered using a specially designed registration form and a more detailed form relating to the colonoscopy itself. The data collected includes: The Colonoscopist endoscopy experience and education, Medicine use, Colonoscopy duration, Unadjusted Caecum Intubations rate, Polyp detection rate, Polyps removed, Cancer detection rate and Nurse assisted Gloucester Comfort score.
Patient level data were recorded using a questionaire with 6 questions regarding satisfaction, pain, discomfort etc on a 10 cm analog scale.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients referred to a colonoscopy | – | Procedure: No intervention, purely observational.A min. of 800 patients referred to colonoscopy at Aalborg University Hospital. The 800 patients are from the out patient clinic. A mix of screening and non-screening patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to colonoscopy at the out patient clinic at Aalborg University department. All patients deemed fit to for at colonoscopy at the outpaient clinic were included. The patient population is a mix of screening and non-screening patients. The study begins in april 2015.
Key inclusion criteria (1 listed)
- All patients referred to colonoscopy at the out-patient clinic at Aalborg University department.
Key exclusion criteria (2 listed)
- Rejection to fill out questionaire.
- Patents referred to AVA (advanced endoscopy unit) were excluded as the are not comparable to regular colonoscopies. Most patients are referred to AVA for specific endoscopy treatments such as large polyp removals etc.
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 |
|---|---|---|
| No intervention, purely observational.No intervention is made other than following existing guidelines for colonoscopy. Further treatment and/or renewed colonoscopy in case of positive findings follows existing guidelines. The group is used only used to collect quality assurance data. | Procedure or surgery | Patients referred to a colonoscopy |
Primary outcome
Patient Satisfaction
Time frame: 1 day
Each patient were given a questionaire with 6 questions answering satisfaction, pain, discomfort etc on a 10 cm analog scale.
2 secondary outcomes
Nurses perception of patients' pain
Time frame: 1 day
Patient Pain (own Perception)
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Background: PubMed 19319384Chartier L, Arthurs E, Sewitch MJ. Patient satisfaction with colonoscopy: a literature review and pilot study. Can J Gastroenterol. 2009 Mar;23(3):203-9. doi: 10.1155/2009/903545.
- Individual participant dataSharing planned: No
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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.
Lasse Pedersen, m.d. principal investigator
Aalborg University Hospital, Surgical Department.
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 Colorectal Cancer, run by Aalborg University Hospital at 1 site in Denmark.
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: withdrawn, as of the sponsor's last update on 5 Jul 2019. 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 Denmark. 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 was withdrawn before enrolling participants, so there are no results.
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?
Patient Satisfaction (time frame: 1 day). 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 NCT02422680, 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 5 Jul 2019.