Colorectal CancerSOCRATECNCT04307901
Safety Of ColoRectal Assessment and Tumor Evaluation by Colon Capsule Endoscopy
An observational study of Colorectal Cancer and Colorectal Polyp, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Following European guidelines patients undergoing colonoscopy in one of Odense University Hospitals units will now be offered a colon capsule endoscopy (CCE) in case of incomplete examinations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Colorectal Polyp
- What is being tested?
- Colon capsule endoscopy
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 600 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2020to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All adults referred to colon capsule endoscopy from the surgical department of Odense University Hospital, which signs consent form enabling us to retrieve personal data.
Who may be able to join
- Incomplete colonoscopy, referral for colonoscopy under general anesthesia or declining colonoscopy after completion of bowel preparation.
Who cannot join
- Chrohn's disease with symptoms of stenosis and/or pacemaker
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital
Svendborg, 5700
Gunnar Baatrup
About this study
Following European guidelines patients undergoing colonoscopy in one of Odense University Hospitals units will now be offered a colon capsule endoscopy (CCE) in case of incomplete examinations. Patients formerly referred to colonoscopy in general anesthesia or patients who decline colonoscopy after having completed bowel preparation will also be offered a CCE. In our department we have conducted a comparison study documenting that the sensitivity of CCE is superior to CT colonography in both polyps >9 mm and polyps >5 mm, which is also supported by an Italian study. The safety and completion rate of CCE following incomplete colonoscopy is confirmed by several studies including one multicenter study and the completion rate is not significantly lower compared to other patient groups. In an incomplete colonoscopy it is always the most oral part of the colon which is not visualized, whereas in CCE, an incomplete investigation will most often have visualized the oral part. By combining incomplete colonoscopy results and incomplete CCE results we can identify patients who have had a complete colon investigation although both investigations were incomplete.
Aim: to investigate the quality of CCE and the completion rate in patients who have undergone an incomplete colonoscopy, have completed bowel preparation but declines colonoscopy or have been referred to colonoscopy in general anesthesia.
- Conditions
- Colorectal Cancer, Colorectal Polyp
- Being tested
- Colon capsule endoscopy
- Keywords
- colon capsule endoscopy, ct colonography, colonoscopy, endoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colon capsule endoscopyDevice
Endoscopy performed using PillCam2 camera capsule for oral ingestion
| Study group | Role | What they receive |
|---|---|---|
| Incomplete colonoscopy | Individuals referred to colon capsule endoscopy due to incomplete colonoscopy investigation. Receives: Device: Colon capsule endoscopy | |
| Colonoscopy general anesthesia | Individuals referred to colon capsule endoscopy as alternative to colonoscopy under general anesthesia. Receives: Device: Colon capsule endoscopy | |
| Colonoscopy declined | Individuals referred to colon capsule endoscopy after completion of bowel preparation for colonoscopy, but who have declined colonoscopy to be carried out. Receives: Device: Colon capsule endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete mucosal visualization combining incomplete investigations
By combining results from incomplete colon capsule endoscopy and incomplete colonoscopy we will identify complete combined investigations.
Measured: 10 years
Secondary outcomes (5)
Completion rate of colon capsule endoscopy
Total and subgroup completion rates of investigations
Measured: 2 years
Safety of colon capsule endoscopy
Total and subgroup safety of investigations
Measured: 1 year
Quality of colon capsule endoscopy
Sensitivity and specificity compared to colonoscopies
Measured: 1 year
Economic evaluation
Economic analyses and evaluations comparing cost of investigations per patient and per case by investigation type.
Measured: 1 year
Patient preference
Investigation of patient preferences stratified by demographic characteristics and history of endoscopic procedures
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start1 May 2020
- Primary completion1 Oct 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
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 Odense 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Issam al-Najami, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307901
- Sponsor's protocol ID
- 20/4408
- Acronym
- SOCRATEC
- Status last verified
- May 2020
- First submitted
- 12 Mar 2020
- Last updated
- 20 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Havshoi AV, Deding U, Jensen SS, Andersen PV, Kaalby L, Al-Najami I. Colon capsule endoscopy following incomplete colonoscopy in routine clinical settings. Surg Endosc. 2023 Apr;37(4):2749-2755. doi: 10.1007/s00464-022-09783-w. Epub 2022 Dec 5.
PubMed 36471059
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Of ColoRectal Assessment and Tumor Evaluation by Colon Capsule Endoscopy
- ClinicalTrials.gov ID
- NCT04307901
- Acronym / sponsor ID
- SOCRATEC / 20/4408
- Conditions
- Colorectal Cancer, Colorectal Polyp
- Keywords
- colon capsule endoscopy, ct colonography, colonoscopy, endoscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Oct 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 13 Mar 2020 (actual)
- 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.
Following European guidelines patients undergoing colonoscopy in one of Odense University Hospitals units will now be offered a colon capsule endoscopy (CCE) in case of incomplete examinations. Patients formerly referred to colonoscopy in general anesthesia or patients who decline colonoscopy after having completed bowel preparation will also be offered a CCE. In our department we have conducted a comparison study documenting that the sensitivity of CCE is superior to CT colonography in both polyps >9 mm and polyps >5 mm, which is also supported by an Italian study. The safety and completion rate of CCE following incomplete colonoscopy is confirmed by several studies including one multicenter study and the completion rate is not significantly lower compared to other patient groups. In an incomplete colonoscopy it is always the most oral part of the colon which is not visualized, whereas in CCE, an incomplete investigation will most often have visualized the oral part. By combining incomplete colonoscopy results and incomplete CCE results we can identify patients who have had a complete colon investigation although both investigations were incomplete.
Aim: to investigate the quality of CCE and the completion rate in patients who have undergone an incomplete colonoscopy, have completed bowel preparation but declines colonoscopy or have been referred to colonoscopy in general anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Incomplete colonoscopy | – | Device: Colon capsule endoscopyIndividuals referred to colon capsule endoscopy due to incomplete colonoscopy investigation. |
| Colonoscopy general anesthesia | – | Device: Colon capsule endoscopyIndividuals referred to colon capsule endoscopy as alternative to colonoscopy under general anesthesia. |
| Colonoscopy declined | – | Device: Colon capsule endoscopyIndividuals referred to colon capsule endoscopy after completion of bowel preparation for colonoscopy, but who have declined colonoscopy to be carried out. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults referred to colon capsule endoscopy from the surgical department of Odense University Hospital, which signs consent form enabling us to retrieve personal data.
Key inclusion criteria (1 listed)
- Incomplete colonoscopy, referral for colonoscopy under general anesthesia or declining colonoscopy after completion of bowel preparation.
Key exclusion criteria (1 listed)
- Chrohn's disease with symptoms of stenosis and/or pacemaker
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 |
|---|---|---|
| Colon capsule endoscopyEndoscopy performed using PillCam2 camera capsule for oral ingestion | Device | Colonoscopy declined, Colonoscopy general anesthesia, Incomplete colonoscopy |
Primary outcome
Complete mucosal visualization combining incomplete investigations
Time frame: 10 years
By combining results from incomplete colon capsule endoscopy and incomplete colonoscopy we will identify complete combined investigations.
5 secondary outcomes
Completion rate of colon capsule endoscopy
Time frame: 2 years
Safety of colon capsule endoscopy
Time frame: 1 year
Quality of colon capsule endoscopy
Time frame: 1 year
Economic evaluation
Time frame: 1 year
Patient preference
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Derived from this study: PubMed 36471059Havshoi AV, Deding U, Jensen SS, Andersen PV, Kaalby L, Al-Najami I. Colon capsule endoscopy following incomplete colonoscopy in routine clinical settings. Surg Endosc. 2023 Apr;37(4):2749-2755. doi: 10.1007/s00464-022-09783-w. Epub 2022 Dec 5.
- Individual participant dataSharing planned: Undecided
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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.
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 and Colorectal Polyp, run by Odense 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 1 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: looking for participants now, as of the sponsor's last update on 20 May 2020. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gunnar Baatrup, Prof. (+4520575154, gunnar.baatrup@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete mucosal visualization combining incomplete investigations (time frame: 10 years). 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 NCT04307901, 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 May 2020.