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Colon Capsule Endoscopy in Patients With Colonic Diverticulitis (CACODI)

Primary Purpose

Diverticulitis, Colonic

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
colon capsule endoscopy
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diverticulitis, Colonic focused on measuring colonic diverticulitis, capsule endoscopy, colonoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients above the age of 18 with in-hospital CT-diagnosed diverticulitis Exclusion Criteria: 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

Sites / Locations

  • Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Colon capsule endoscopy

Colonoscopy

Arm Description

Patients randomized to colon capsule endoscopy

Patients randomized to colonoscopy

Outcomes

Primary Outcome Measures

Patient discomfort and preference
These patient-reported outcomes as well as an evaluation on patient preferences will be investigated using questionnaires

Secondary Outcome Measures

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
Number of neoplastic lesions
Neoplastic lesions detected by colon capsule endoscopy or colonoscopy

Full Information

First Posted
January 17, 2023
Last Updated
September 8, 2023
Sponsor
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05700981
Brief Title
Colon Capsule Endoscopy in Patients With Colonic Diverticulitis
Acronym
CACODI
Official Title
Colon Capsule Endoscopy in Patients With Colonic Diverticulitis: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Odense University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diverticulitis, Colonic
Keywords
colonic diverticulitis, capsule endoscopy, colonoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized controlled trials
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Colon capsule endoscopy
Arm Type
Experimental
Arm Description
Patients randomized to colon capsule endoscopy
Arm Title
Colonoscopy
Arm Type
No Intervention
Arm Description
Patients randomized to colonoscopy
Intervention Type
Diagnostic Test
Intervention Name(s)
colon capsule endoscopy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient discomfort and preference
Description
These patient-reported outcomes as well as an evaluation on patient preferences will be investigated using questionnaires
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Re-investigation rate
Description
The number of patients randomized to colon capsule endoscopy that need to undergo a subsequent colonoscopy due to neoplastic findings or incomplete examination
Time Frame
6 months
Title
Number of neoplastic lesions
Description
Neoplastic lesions detected by colon capsule endoscopy or colonoscopy
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients above the age of 18 with in-hospital CT-diagnosed diverticulitis Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Bjørsum-Meyer, M.D., PhD
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odense University Hospital
City
Odense
State/Province
Funen
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
1/1-2023 - 31/12-2023
IPD Sharing Access Criteria
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan and execution of a Data Sharing Agreement.

Learn more about this trial

Colon Capsule Endoscopy in Patients With Colonic Diverticulitis

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