No registrations found.
ID
Source
Brief title
Health condition
Randomized control trial
Colonic Polyps/diagnosis*
Colorectal Neoplasms/diagnosis*
Colonic Polyps/pathology*
Colonoscopy*/economics
Health care costs
Sensitivity and Specificity
Hospitals, community
Early Detection of Cancer
Eventueel:
Male
Female
Adult
Middle aged
Sponsors and support
Dutch Maag-Lever-Darm Stichting
Intervention
Outcome measures
Primary outcome
Primary aims
1) Number of training rounds needed to reach clinically acceptable prediction of histology (accuracy > 90%) for colorectal lesions
2) To assess whether qualified endoscopists are able to maintain this performance over a year, and if feedback is of additional value
Secondary outcome
Secondary aims:
1) number of endoscopists reaching NPV > 90% for predicting neoplastic histology in continuation phase
2) number of correctly advised surveillance intervals
3) number of correctly predicted diminutive (1-5mm) lesions
4) number of surveillance intervals predicted on endoscopic diagnosis
5) number of correctly diagnosed small (6-9mm) lesions
6) budget impact analysis
Study objective
1) Whether endoscopists are able to learn optical diagnosis of colonic polyps using NBI by a validated training and feedback program
2) Whether these endoscopists are able to reach the threshold provided by the PIVI guidelines for predicting the diagnosis of diminutive lesions
3) Whether regular measurement and feedback of optical diagnosis will be needed to assure the quality of this optical diagnosis strategy.
Study design
- 3-monthly feedback with up-to-date accuracy, negative predictive value, sensitivity and specificity on optical diagnosis of diminutive (1-5mm) and small (6-9mm) polyps.
- Overview of NICE/WASP/KUDO optical diagnosis principles
Intervention
Validated training, qualification and 3-monthly feedback
Department of Gastroenterology and Hepatology <br>
P.O. Box 22660
Evelien Dekker
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5664702
e.dekker@amc.uva.nl
Department of Gastroenterology and Hepatology <br>
P.O. Box 22660
Evelien Dekker
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5664702
e.dekker@amc.uva.nl
Inclusion criteria
Patients: all those with polyps who receive a coloscopy in the context of the Dutch bowel cancer screening program
Endoscopists: all those who are accredited to perform colonoscopies for the nationwide Dutch bowel colorectal cancer screening program
Exclusion criteria
Patients with inflammatory bowel disease. Patients who had a CRC before.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4517 |
| NTR-old | NTR4635 |
| Other | METC AMC: W14_099 : MLDS: FP-13 |