To determine the efficacy, safety and patient tolerability of spiral endoscopy for use in colonoscopy.
ID
Source
Brief title
Condition
- Gastrointestinal signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the proportion of subjects with complete colon
examination to the cecum using spiral colonoscopy.
Secondary outcome
Secondary endpoints include endoscopic procedural data including time-to-cecum,
total procedural time, rate of terminal ileal intubation, endoscopic diagnostic
yield, data regarding safety and adverse events, and patient tolerability data
assessed using a comfort/discomfort visual analogue scale.
Background summary
Complete examination of the colon is important for all patients undergoing
colonoscopy. There are certain patient groups for whom completing colonoscopy
to cecal intubation or ileocolonoscopy to terminal ileal intubation is
particularly difficult. Currently, patients with failed colonoscopy need to
undergo a repeat colonoscopy. Spiral endoscopy is a new endoscopic method
developed for use in small bowel enteroscopy that has particular advantages
making it a potentially very attractive tool for use in colonoscopy.
Study objective
To determine the efficacy, safety and patient tolerability of spiral endoscopy
for use in colonoscopy.
Study design
Pilot study with a prospective, observational cohort design.
Study burden and risks
Study participation entails undergoing colonoscopy using the new spiral
endoscopy method, which is expected to be faster than conventional colonoscopy
with a similar risk profile. The alternative for patients who decline study
participation is to simply repeat conventional colonoscopy. Study participation
also involves completing a visual analogue scale of comfort/discomfort before
and after the procedure as well as one day post-procedure, and answering a
brief telephone call 30 days post-procedure regarding any possible adverse
events. The total expected time commitment to complete the visual analogue
scales and for the telephone call is less than 5 minutes.
's Gravendijkswal 230
2993 CG
NL
's Gravendijkswal 230
2993 CG
NL
Listed location countries
Age
Inclusion criteria
1) Adult patient 18 years-old or older
2) Able to read/write in Dutch
3) Previously attempted colonoscopy that failed to reach cecum
4) Previously attempted ileocolonscopy that failed to intubate the terminal ileum for patients with suspected Crohn*s disease.
Exclusion criteria
1) Age < 18 years
2) Unable to provide informed consent
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 | NL30436.078.09 |