N/A
Completed N=208
Cap-assisted Water Immersion Versus Water Immersion Colonoscopy
Colonoscopy
Source: ClinicalTrials.gov NCT01547247 ↗
Enrolled (actual)
208
Serious AEs
—
Results posted
Jan 2013
Primary outcomePrimary: Cecal Intubation Time — 6.9; 7.4 minutes
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.
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 | — |
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. Informational only — not medical advice.