To compare accuracy, patient experience and costs of lower gastrointestinal endoscopy (sigmoidoscopy and colonoscopy) between nurse and physician endoscopists.
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: diagnostic accuracy for finding lesions in the colon
Secondary outcome
Secundary outcome: patient experience (complications; pain/discomfort during
and symptoms after the procedure, satisfaction, preferences;
costs/cost-effectiveness.
Background summary
The demand for diagnostic and therapeutic flexible endoscopy of the
gastrointestinal (GI) tract is rapidly increasing. This is caused by various
factors such as demographic changes, the introduction of new techniques, and
the increased attention for screening and surveillance of premalignant
conditions such as adenomatous polyps of the colon. Therefore, there is an
increased need in the number of gastroenterologists in the Netherlands.
In several countries that have experienced increases in the use of flexible
endoscopy, the introduction of nurse endoscopists has contributed to a solution
for the shortage of endoscopists and a reduction in waiting lists. Nurse
endoscopists have found to provide good patient care in the majority of
endoscopy units with no compromises on safety. The introduction of nurse
endoscopy of the colon also seems to lead to significant cost-savings.
Further study of the efficacy and safety of nurse endoscopy of the colon is
required. In addition, patient experiences and economical aspects need to be
evaluated. Nurses may potentially play an important role in performing colon
endoscopy, but further systematic study is required before widespread
implementation is recommended in the Netherlands.
Study objective
To compare accuracy, patient experience and costs of lower gastrointestinal
endoscopy (sigmoidoscopy and colonoscopy) between nurse and physician
endoscopists.
Study design
This study will be performed at the Erasmus MC Rotterdam and Maastricht
University Medical Center. Other centers consider to participate in the study.
In a period of 2,5 years 4000 patients referred for a diagnostic lower
endoscopy will be asked to participate in this study.
This study consists of three parts:
a) Part I (2400 patients): training
b) Part II (1600 patients): to determine wether there is a differnce in patient
experience, the number of complications, and costs between nurse endoscopists
and physian endoscopists.
Study burden and risks
There is no extra risk for patients participating in this study. During any
colonoscopy a perforation can occur (1 in 1000 and 1 in 100 after a
polypectomy).
's Gravendijkwal 230
3015 CE Rotterdam
NL
's Gravendijkwal 230
3015 CE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Patients referred for diagnostic sigmoidoscopy and colonoscopy and signed informed consent
Exclusion criteria
Patients referred for a therapeutic colonoscopy (removal of an eary stage colorectal cancer).
Patients referred for diagnostic (sigmoidoscopy or) colonoscopy who are participating in the screening project for colorectal cancer.
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 |
---|---|
CCMO | NL17490.078.07 |