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Investigation of the analysis quality of PillCam Colon Capsule endoscopy of Doctors and Nurses compared to experts - RCT.

Investigation of the analysis quality of PillCam Colon Capsule endoscopy of Doctors and Nurses compared to experts - RCT.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00000324
Enrollment
18
Registered
2010-05-25
Start date
2009-05-25
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analysis of interpretation quality of PillCam Colon- Capsule endoscopy films by different medical staff compared to experts

Interventions

Group 1: Group A include 9 endoscopy nurses or nurse assistants who assisted at least 300 colonoscopies independent. All 9 study participants in group A have to analyse 30 randomized capsule endoscop

Sponsors

Stiftung Evengelisches Krankenhaus Düsseldorf
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Included have been nurses who should have completed further education in endoscopy nursing and physicians who should be at least general practitioner (internist). Both staff should have experience with at least or more 300 colonoscopies which should be done independent and both staff groups shouldn`t have experience in capsule endoscopy

Exclusion criteria

Exclusion criteria: Excluded have been nurses who do not have further education in endoscopy nursing and who physicians do not have an examen for general practitioner (internist). Both staff groups have less experience then 300 colonoscopies and have already experience in capsule endoscopy

Design outcomes

Primary

MeasureTime frame
The primary endpoint of the study is the proof to a comparable high sensitivity between nurses and physicians compared to experts.

Secondary

MeasureTime frame
Secundary endpoints are: a. comparison of the specifity of the detection of polyps of doctors and nurses comparing to the results of experts (Golden Standard). b. comparison of the number of polyps between doctors and nurses c. comparison of the polyp size (=> 10 mm) between doctors and nurses d. comparison of the needed time for analysis between doctors and nurses f. Comparison of the years of occupation and the number of both carried out and assisted colonoscopies between doctors and nurses

Countries

Germany

Contacts

Public ContactUte Pfeifer

Stiftung Evangelisches Krankenhaus Düsseldorf

Ute.Pfeifer@evk-duesseldorf.de0211-9191154

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026