Colonoscopy Clinical Trials

Clinical trials related to Colonoscopy Procedure

Camera Capsule Endoscopy in the Routine Diagnostic Pathway for Colorectal Diseases

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The Department of Surgery at Odense University Hospital (OUH) carries out approximately 10,000 colonoscopies each year, and this number is continuously increasing. Since 2014, the screening for colorectal cancer (CRC) has resulted in a significant increase in the colonoscopy workload. Conventional colonoscopy (CC) is a hospital-based procedure that can require sedation or analgesics and is often considered uncomfortable, intimidating, or even painful. The diagnostic yield of CC can be as low as 3-5% in some patient groups, which means that an endoscopist may need to perform 20 to 30 colonoscopies to identify one case requiring treatment. Physical or cultural barriers can also deter patients from attending appointments, leading to missed cancers or precancerous lesions. To address these challenges, an alternative pathway is needed to reduce the colonoscopy burden on the healthcare system while ensuring fewer findings are missed. One solution is to use Colon Capsule Endoscopy (CCE) as a triage tool. This procedure can be performed in outpatient healthcare centers and requires less equipment than an CC. However, CCE offers no therapeutic capability, and individuals with clinically significant findings will still require an CC. A low reinvestigation rate (\<25%-30%) is desirable for patient preference and the economy. Therefore, DanCap will introduce a new pathway that relies on CCE for routine colorectal examinations of symptomatic patients who are expected to have a low rate of positive findings and, consequently, a low reinvestigation rate, and asses the cost of this new pathway.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Older than 18 years

• Symptomatic patient referred for colonoscopy assessment

• Able to provide oral and written informed consent

Locations
Other Locations
Denmark
Odense University Hospital
RECRUITING
Odense C
Contact Information
Primary
Anastasios Koulaouzidis, Professor
Anastasios.Koulaouzidis@rsyd.dk
23 41 49 95
Backup
Alexandra D Agache, Postdoc
Alexandra.Agache@rsyd.dk
20 35 57 17
Time Frame
Start Date: 2024-11-27
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 800
Treatments
Active_comparator: CCE arm
Symptomatic patients referred by their GP for a 2 week diagnostic lower gastrointestinal procedure will be randomized in clusters determined by the GP clinic provider number. At the start of the project, odd provider numbers will be referred to CC, and even provider numbers will be referred to CCE. After the inclusion of the first 200 consecutive CCE patients, the two arms will be swapped, i.e., patients from clinics with even provider numbers are referred for CC, and odd provider numbers are referred for CCE.
Placebo_comparator: CC arm
Symptomatic patients referred by their GP for a 2 week diagnostic lower gastrointestinal procedure will be randomized in clusters determined by the GP clinic provider number. At the start of the project, odd provider numbers will be referred to CC, and even provider numbers will be referred to CCE. After the inclusion of the first 200 consecutive CCE patients, the two arms will be swapped, i.e., patients from clinics with even provider numbers are referred for CC, and odd provider numbers are referred for CCE.
Related Therapeutic Areas
Sponsors
Leads: Odense University Hospital
Collaborators: Region Syddanmark

This content was sourced from clinicaltrials.gov