Safety Of ColoRectal Assessment and Tumor Evaluation by Colon Capsule Endoscopy

NCT ID: NCT04307901

Last Updated: 2020-05-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2030-12-31

Brief 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. 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Incomplete colonoscopy

Individuals referred to colon capsule endoscopy due to incomplete colonoscopy investigation.

Colon capsule endoscopy

Intervention Type: DEVICE

Endoscopy performed using PillCam2 camera capsule for oral ingestion

Colonoscopy general anesthesia

Individuals referred to colon capsule endoscopy as alternative to colonoscopy under general anesthesia.

Colon capsule endoscopy

Intervention Type: DEVICE

Endoscopy performed using PillCam2 camera capsule for oral ingestion

Colonoscopy declined

Individuals referred to colon capsule endoscopy after completion of bowel preparation for colonoscopy, but who have declined colonoscopy to be carried out.

Colon capsule endoscopy

Intervention Type: DEVICE

Endoscopy performed using PillCam2 camera capsule for oral ingestion

Interventions

Colon capsule endoscopy

Endoscopy performed using PillCam2 camera capsule for oral ingestion

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Incomplete colonoscopy, referral for colonoscopy under general anesthesia or declining colonoscopy after completion of bowel preparation.

Exclusion Criteria

• Chrohn's disease with symptoms of stenosis and/or pacemaker

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Issam al-Najami

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Odense University Hospital

Svendborg, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Gunnar Baatrup, Prof.

Role: CONTACT

gunnar.baatrup@rsyd.dk

+4520575154

Facility Contacts

Gunnar Baatrup

Role: primary

References

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.

Reference Type: DERIVED

PMID: 36471059 (View on PubMed)

Other Identifiers

20/4408

Identifier Type: -

Identifier Source: org_study_id