Training Effects in Colonoscopy

Adenoma Detection Rate Clinical Trial

— TraCo  

Official title:

The Impact of Training Effects on Quality Indicators in Colonoscopy: a Retrospective Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01786213
• Other study ID #: TraCo
• Status: Completed
• Phase: N/A
• First received: February 5, 2013
• Last updated: February 5, 2014
• Start date: February 2013
• Est. completion date: January 2014

Study information

• Verified date: February 2013
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

Colon cancer is the second most common cause of death among cancer-related deaths in Germany. Precancerous lesions such as adenomas can be detected efficiently by colonoscopy. To provide high quality in colonoscopy several quality parameters have been postulated in the past. The adenoma detection rate (ADR) is one of those parameters. Empirical data suggest that a detection rate of 20% should be demanded. Detection rates are influenced by a multitude of circumstances such as bowel cleanness. The facts that detection rates vary between colonoscopists suggests that leaning effects may also play a role. It is not known how ADR and other quality parameters evolve while trainees improve their skills in colonoscopy. The investigators postulate that a learning curve exists. The investigators therefore plan to evaluate chronologically the findings of trainee colonoscopists. A particular performance in detecting adenomas shall be calculated in relation to the amount of examinations performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3500
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• colonoscopy performed at the Technical University Munich, Germany

Exclusion Criteria:

• colonoscopy performed for the purpose of polypectomy

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Adenoma Detection Rate

Locations

Country	Name	City	State
Germany	Medizinische Klinik und Poliklinik der Technischen Universität München	Munich	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Amount of sedative used		every 50 exmainations	No
Primary	Adenoma detection rate	While numbers of investigations rise new detection rates are calculated for each colonoscopist.	every 50 examinations	No
Secondary	Polyp detection rate		every 50 examinations	No