Cap-assisted Water Immersion Versus Water Immersion Colonoscopy

Vitkovice Hospital

Status: Completed

Conditions: Colonoscopy

Treatments: Procedure: water immersion colonoscopy; Device: soft straight distal cap D-201-14304 Olympus attached to the tip of the colonoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT01547247

DDC VN 03

Details and patient eligibility

About

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.

Enrollment: 208 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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208 participants in 2 patient groups

cap-assisted water immersion colonoscopy

Experimental group

Description:

Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.

Treatment:

Device: soft straight distal cap D-201-14304 Olympus attached to the tip of the colonoscope

water immersion colonoscopy

Active Comparator group

Description:

Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.

Treatment:

Procedure: water immersion colonoscopy