Safety Of ColoRectal Assessment and Tumor Evaluation by Colon Capsule Endoscopy (SOCRATEC)

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 Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Colorectal Polyp
• Intervention / Treatment: Device: Colon capsule endoscopy

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Gunnar Baatrup, Prof.; Phone Number: +4520575154; Email: gunnar.baatrup@rsyd.dk

Study Locations

• Denmark
  • Svendborg, Denmark, 5700
    • Recruiting
    • Odense University Hospital
    • Contact: Gunnar Baatrup

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Incomplete colonoscopy; Individuals referred to colon capsule endoscopy due to incomplete colonoscopy investigation.	Device: Colon capsule endoscopy; 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.	Device: Colon capsule endoscopy; 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.	Device: Colon capsule endoscopy; Endoscopy performed using PillCam2 camera capsule for oral ingestion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete mucosal visualization combining incomplete investigations	By combining results from incomplete colon capsule endoscopy and incomplete colonoscopy we will identify complete combined investigations.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion rate of colon capsule endoscopy	Total and subgroup completion rates of investigations	2 years
Safety of colon capsule endoscopy	Total and subgroup safety of investigations	1 year
Quality of colon capsule endoscopy	Sensitivity and specificity compared to colonoscopies	1 year
Economic evaluation	Economic analyses and evaluations comparing cost of investigations per patient and per case by investigation type.	1 year
Patient preference	Investigation of patient preferences stratified by demographic characteristics and history of endoscopic procedures	2 years

Collaborators and Investigators

• Sponsor: Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Anticipated): October 1, 2030
• Study Completion (Anticipated): December 31, 2030

Study Registration Dates

• First Submitted: March 12, 2020
• First Submitted That Met QC Criteria: March 12, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): May 20, 2020
• Last Update Submitted That Met QC Criteria: May 18, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: colonoscopy; endoscopy; colon capsule endoscopy; ct colonography
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 20/4408

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes