Diverticulitis, ColonicCACODINCT05700981
Colon Capsule Endoscopy in Patients With Colonic Diverticulitis
A study testing colon capsule endoscopy in people with Diverticulitis, Colonic, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Introduction: Follow-up after colonic diverticulitis is a common indication for colonoscopy, even though studies have shown a low risk of positive findings in this population. The objective is to investigate colon capsule endoscopy (CCE) as a follow-up examination in patients with colonic diverticulitis compared to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticulitis, Colonic
- What is being tested?
- colon capsule endoscopy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2023to 30 Jun 2024
- 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 above the age of 18 with in-hospital CT-diagnosed diverticulitis
Who cannot join
- Recent imaging of the colonic mucosa and therefore no indication for renewed endoscopy, evaluated by the attending physician.
- Colonic CT findings that require biopsy (suspected cancer) or polyp removal.
- CT-verified stenosis in the gastrointestinal (GI) tract.
- Cardiac pacemaker
- Renal insufficiency
- Pregnancy/breastfeeding
- Allergies towards active substances administered in the trial
- Unable to provide oral and written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Colon Capsule Endoscopy in Patients With Colonic Diverticulitis: a Randomized Controlled Trial
Introduction: Follow-up after colonic diverticulitis is a common indication for colonoscopy, even though studies have shown a low risk of positive findings in this population. The objective is to investigate colon capsule endoscopy (CCE) as a follow-up examination in patients with colonic diverticulitis compared to colonoscopy, on patient satisfaction and clinical performance.
Methods and Analysis: The investigators will conduct a single centre prospective randomized controlled trial. Patients seen at Odense University Hospital with acute diverticulitis confirmed by CT will be included and randomized to either follow-up by colonoscopy or CCE. Detection of suspected cancer, more than two polyps or any number of polyps larger than 9mm in CCE will generate an invitation to a diagnostic colonoscopy for biopsies or polyp removal. The investigators will compare colonoscopy and CCE regarding patient satisfaction and tolerance, the number of complete examinations, the number of patients referred to a subsequent colonoscopy after CCE and the prevalence of diverticula, polyps, cancers and other abnormal findings.
Read the detailed description
Colon diverticulosis (CD) is extremely common and the prevalence seems to increase globally. The prevalence of CD increases with age and two-thirds of the adult population eventually develop CD. In the US the prevalence of CD was 32.6 % in patients aged 50-59 years and 71.4% in patients > 80 years of age. CD is often detected incidentally during optical colonoscopy (OC) or by computer tomography (CT). In approximately 25 % of patients with CD symptomatic colon diverticular disease develop typically comprising bloating, abdominal pain and change in bowel habits. Progression to diverticulitis is estimated to appear in approximately 1%. Most patients present with uncomplicated diverticulitis and are managed by general practitioners (GP) with the use of painkillers and oral antibiotics. Complicated diverticulitis due to perforation can be classified according to Hinchey et al. as a guidance to surgeon as to how conservative they can be. Hinchey level 1-2 can be managed conservatively. In the case of Hinchey level 3 and 4 it requires a laparoscopy with peritoneal lavage or laparotomy with colon resection and stoma formation, respectively. In patients presenting at the GP with intractable pain or signs of sepsis admission to hospital services is mandatory. Upon hospitalization, CT is the preferred diagnostic imaging modality in patients presenting with abdominal pain and suspected diverticulitis. If colonic diverticulitis is described as the symptoms-eliciting pathology without complications comprising abscess or bowel perforation patients are typically discharged from hospital with painkillers and offered an OC within 4-6 weeks, when the inflammation has resolved, to confirm the diverticulitis diagnosis. Routine OC after an episode of diverticulitis is recommended by the majority of international guidelines including Danish guidelines on handling of patients with diverticulitis. Due to a very low risk of malignancy in patients with diverticulitis the relevance of routine OC has been questioned in a recent review. The research in Colon Capsule Endoscopy (CCE) has evolved substantially since the introduction in 2006. More studies have reported a diagnostic yield equal to OC also in regard to larger polyps > 9 mm. In contrast to OC, CCE does not offer the possibility of biopsy or removal polyp. Hence, the ideal population for CCE needs to have low risk of findings with the need of endoscopic intervention. CCE is without pain and the risk of complications is extremely low compared to colonoscopy for which the estimated risk of major bleeding or perforation is 12 per 10,000 patients.
The investigators aimed to evaluate the effect of introducing CCE on patient satisfaction and discomfort compared to colonoscopy as a follow-up examination in patients with diverticulitis and the impact of introducing CCE on the need for subsequent colonoscopy.
- Conditions
- Diverticulitis, Colonic
- Being tested
- colon capsule endoscopy
- Keywords
- colonic diverticulitis, capsule endoscopy, colonoscopy
- Medical subject headings
- Diverticulitis, Colonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colon capsule endoscopyDiagnostic test
Patient allocated for the intervention arm will have a CCE using the PillCam Colon 2 (Medtronic, Minneapolis, Minnesota, USA). Upon inclusion and allocation to the intervention arm patients are contacted by a dedicated CCE nurse. The course of the CCE procedure and preparations are explained thoroughly. In case of additional questions patients can contact the nurses by telephone during office hours (Monday-Friday, 8am-3pm). Before the CCE participants will have to undergo a bowel preparation procedure. The bowel preparation kit will be distributed by mail and is to be completed at home, beginning 72 hours before the CCE. The kit contains polyethylene glycol (PEG) sachets (Movicol, Norgine Danmark A/S, Herlev, Denmark), PEG solutions (MoviPrep, Norgine Danmark A/S, Herlev Denmark) and instructions on how to properly perform the preparation procedures.
| Study group | Role | What they receive |
|---|---|---|
| Colon capsule endoscopy | Experimental | Patients randomized to colon capsule endoscopy Receives: Diagnostic Test: colon capsule endoscopy |
| Colonoscopy | No intervention | Patients randomized to colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient discomfort and preference
These patient-reported outcomes as well as an evaluation on patient preferences will be investigated using questionnaires
Measured: 6 months
Secondary outcomes (2)
Re-investigation rate
The number of patients randomized to colon capsule endoscopy that need to undergo a subsequent colonoscopy due to neoplastic findings or incomplete examination
Measured: 6 months
Number of neoplastic lesions
Neoplastic lesions detected by colon capsule endoscopy or colonoscopy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Feb 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (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 Diverticulitis, ColonicStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trials
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Bjørsum-Meyer, M.D., PhD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700981
- Sponsor's protocol ID
- CACODI trial
- Acronym
- CACODI
- Status last verified
- Jan 2023
- First submitted
- 17 Jan 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Relevant anonymized data are available upon reasonable request. Data requesters should do the following to obtain data: Email the corresponding author for the paper to request the relevant data.
Publications
Schelde-Olesen B, Kaalby L, Deding U, Thygesen MMI, Andersen PV, Koulaouzidis A, Baatrup G, Bjorsum-Meyer T. Colon CApsule endoscopy compared to conventional COlonoscopy in patients with colonic DIverticulitis: the study protocol for a randomised controlled superiority trial (CACODI trial). BMJ Open. 2023 Oct 6;13(10):e073575. doi: 10.1136/bmjopen-2023-073575.
PubMed 37802611
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colon Capsule Endoscopy in Patients With Colonic Diverticulitis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05700981
- Acronym / sponsor ID
- CACODI / CACODI trial
- Conditions
- Diverticulitis, Colonic
- Keywords
- colonic diverticulitis, capsule endoscopy, colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 26 Jan 2023 (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.
Introduction: Follow-up after colonic diverticulitis is a common indication for colonoscopy, even though studies have shown a low risk of positive findings in this population. The objective is to investigate colon capsule endoscopy (CCE) as a follow-up examination in patients with colonic diverticulitis compared to colonoscopy, on patient satisfaction and clinical performance.
Methods and Analysis: The investigators will conduct a single centre prospective randomized controlled trial. Patients seen at Odense University Hospital with acute diverticulitis confirmed by CT will be included and randomized to either follow-up by colonoscopy or CCE. Detection of suspected cancer, more than two polyps or any number of polyps larger than 9mm in CCE will generate an invitation to a diagnostic colonoscopy for biopsies or polyp removal. The investigators will compare colonoscopy and CCE regarding patient satisfaction and tolerance, the number of complete examinations, the number of patients referred to a subsequent colonoscopy after CCE and the prevalence of diverticula, polyps, cancers and other abnormal findings.
Detailed description
Colon diverticulosis (CD) is extremely common and the prevalence seems to increase globally. The prevalence of CD increases with age and two-thirds of the adult population eventually develop CD. In the US the prevalence of CD was 32.6 % in patients aged 50-59 years and 71.4% in patients > 80 years of age. CD is often detected incidentally during optical colonoscopy (OC) or by computer tomography (CT). In approximately 25 % of patients with CD symptomatic colon diverticular disease develop typically comprising bloating, abdominal pain and change in bowel habits. Progression to diverticulitis is estimated to appear in approximately 1%. Most patients present with uncomplicated diverticulitis and are managed by general practitioners (GP) with the use of painkillers and oral antibiotics. Complicated diverticulitis due to perforation can be classified according to Hinchey et al. as a guidance to surgeon as to how conservative they can be. Hinchey level 1-2 can be managed conservatively. In the case of Hinchey level 3 and 4 it requires a laparoscopy with peritoneal lavage or laparotomy with colon resection and stoma formation, respectively. In patients presenting at the GP with intractable pain or signs of sepsis admission to hospital services is mandatory. Upon hospitalization, CT is the preferred diagnostic imaging modality in patients presenting with abdominal pain and suspected diverticulitis. If colonic diverticulitis is described as the symptoms-eliciting pathology without complications comprising abscess or bowel perforation patients are typically discharged from hospital with painkillers and offered an OC within 4-6 weeks, when the inflammation has resolved, to confirm the diverticulitis diagnosis. Routine OC after an episode of diverticulitis is recommended by the majority of international guidelines including Danish guidelines on handling of patients with diverticulitis. Due to a very low risk of malignancy in patients with diverticulitis the relevance of routine OC has been questioned in a recent review. The research in Colon Capsule Endoscopy (CCE) has evolved substantially since the introduction in 2006. More studies have reported a diagnostic yield equal to OC also in regard to larger polyps > 9 mm. In contrast to OC, CCE does not offer the possibility of biopsy or removal polyp. Hence, the ideal population for CCE needs to have low risk of findings with the need of endoscopic intervention. CCE is without pain and the risk of complications is extremely low compared to colonoscopy for which the estimated risk of major bleeding or perforation is 12 per 10,000 patients.
The investigators aimed to evaluate the effect of introducing CCE on patient satisfaction and discomfort compared to colonoscopy as a follow-up examination in patients with diverticulitis and the impact of introducing CCE on the need for subsequent colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized controlled trials
| Arm | Type | Receives |
|---|---|---|
| Colon capsule endoscopy | Experimental | Diagnostic Test: colon capsule endoscopyPatients randomized to colon capsule endoscopy |
| Colonoscopy | No intervention | –Patients randomized to colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients above the age of 18 with in-hospital CT-diagnosed diverticulitis
Key exclusion criteria (8 listed)
- Recent imaging of the colonic mucosa and therefore no indication for renewed endoscopy, evaluated by the attending physician.
- Colonic CT findings that require biopsy (suspected cancer) or polyp removal.
- CT-verified stenosis in the gastrointestinal (GI) tract.
- Cardiac pacemaker
- Renal insufficiency
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 endoscopyPatient allocated for the intervention arm will have a CCE using the PillCam Colon 2 (Medtronic, Minneapolis, Minnesota, USA). Upon inclusion and allocation to the intervention arm patients are contacted by a dedicated CCE nurse. The course of the CCE procedure and preparations are explained thoroughly. In case of additional questions patients can contact the nurses by telephone during office hours (Monday-Friday, 8am-3pm). Before the CCE participants will have to undergo a bowel preparation procedure. The bowel preparation kit will be distributed by mail and is to be completed at home, beginning 72 hours before the CCE. The kit contains polyethylene glycol (PEG) sachets (Movicol, Norgine Danmark A/S, Herlev, Denmark), PEG solutions (MoviPrep, Norgine Danmark A/S, Herlev Denmark) and instructions on how to properly perform the preparation procedures. | Diagnostic test | Colon capsule endoscopy |
Primary outcome
Patient discomfort and preference
Time frame: 6 months
These patient-reported outcomes as well as an evaluation on patient preferences will be investigated using questionnaires
2 secondary outcomes
Re-investigation rate
Time frame: 6 months
Number of neoplastic lesions
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Derived from this study: PubMed 37802611Schelde-Olesen B, Kaalby L, Deding U, Thygesen MMI, Andersen PV, Koulaouzidis A, Baatrup G, Bjorsum-Meyer T. Colon CApsule endoscopy compared to conventional COlonoscopy in patients with colonic DIverticulitis: the study protocol for a randomised controlled superiority trial (CACODI trial). BMJ Open. 2023 Oct 6;13(10):e073575. doi: 10.1136/bmjopen-2023-073575.
- Individual participant dataSharing planned: Yes. Relevant anonymized data are available upon reasonable request. Data requesters should do the following to obtain data: Email the corresponding author for the paper to request the relevant data.
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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.
Thomas Bjørsum-Meyer, M.D., PhD principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing colon capsule endoscopy in people with Diverticulitis, Colonic, 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 8 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: status not confirmed, as of the sponsor's last update on 11 Sep 2023. 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?
Results are not available in the source record.
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 discomfort and preference (time frame: 6 months). 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 NCT05700981, 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 11 Sep 2023.