N/A
N=208
Cap-assisted Water Immersion Versus Water Immersion Colonoscopy
Colonoscopy
Bottom Line
View on ClinicalTrials.gov: NCT01547247 ↗Enrolled (actual)
208
Serious AEs
—
Results posted
Jan 2013
Primary outcome: Primary: Cecal Intubation Time — 6.9; 7.4 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- soft straight distal cap D-201-14304 Olympus attached to the tip of the colonoscope (Device); water immersion colonoscopy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vitkovice Hospital
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cecal Intubation Time |
6.9; 7.4 | — |
| SECONDARY Patient Comfort During Insertion Phase of the Colonoscopy |
— | — |
| SECONDARY Success Rate of Minimal Sedation Colonoscopy |
91; 91 | — |
Summary
Water immersion insertion has been documented to decrease procedure-related discomfort during colonoscopy. Cap attached to the colonoscope tip may improve insertion and shorten cecal intubation time. The investigators would like to assess whether combination of cap-fitted colonoscopy and water immersion insertion is feasible and safe method of diagnostic colonoscopy. The primary endpoint is cecal intubation time and the investigators suppose that the use of cap is able to shorten it significantly. Patient comfort during colonoscope insertion, water consumption, length of the scope while reaching the cecum, need for external compression, need for positioning of the patient and endoscopist´s difficulty with colonoscopy are assessed.
Eligibility Criteria
Inclusion Criteria
- outpatient diagnostic colonoscopy
- bowel prep with macrogolum
- initial 2 mg of midazolam i.v.
- signed informed consent form
Exclusion Criteria
- planned therapeutic intervention
- colorectal surgery in history
- known inflammatory bowel disease or colorectal cancer
- refusal of sedation
Data sourced from ClinicalTrials.gov (NCT01547247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.