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NCT Number: NCT04307901

Safety Of ColoRectal Assessment and Tumor Evaluation by Colon Capsule Endoscopy

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Odense University Hospital

Svendborg, 5700, Denmark

Location status: Recruiting

Location contact

Gunnar Baatrup

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COLON Capsule endoscopy

Device

Endoscopy performed using PillCam2 camera capsule for oral ingestion

Primary outcomes

  1. Complete mucosal visualization combining incomplete investigations

    Time frame: 10 years

    By combining results from incomplete colon capsule endoscopy and incomplete colonoscopy we will identify complete combined investigations.

Secondary outcomes

  1. Completion rate of colon capsule endoscopy

    Time frame: 2 years

    Total and subgroup completion rates of investigations

  2. Safety of colon capsule endoscopy

    Time frame: 1 year

    Total and subgroup safety of investigations

  3. Quality of colon capsule endoscopy

    Time frame: 1 year

    Sensitivity and specificity compared to colonoscopies

  4. Economic evaluation

    Time frame: 1 year

    Economic analyses and evaluations comparing cost of investigations per patient and per case by investigation type.

  5. Patient preference

    Time frame: 2 years

    Investigation of patient preferences stratified by demographic characteristics and history of endoscopic procedures

Study contacts

Contact information is provided by the study sponsor or research team.

Gunnar Baatrup, Prof.

CONTACT

[email protected]

+4520575154

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Acronym: SOCRATEC

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Mar 13, 2020
Registry last updated
May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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