Combination of Water Immersion and Carbon Dioxide Insufflation for Minimal Sedation Colonoscopy (Water/CO2)

Vitkovice Hospital

Status: Completed

Conditions: Colonoscopy

Treatments: Procedure: Water immersion insertion AND CO2 insufflation; Procedure: Water immersion insertion; Procedure: CO2 insufflation

Study type: Interventional

Funder types: Other

Identifiers

NCT01440543

DDC VN 01

Details and patient eligibility

About

Water immersion insertion and carbon dioxide (CO2)instead of room air insufflation as alternative colonoscopy techniques have been documented to decrease patient discomfort during and after the procedure.

This prospective, randomized, single-center trial was designed to evaluate whether the combination of water immersion during insertion and CO2 insufflation during withdrawal (Water/CO2)for minimal sedation colonoscopy (2 mg of midazolam i.v.)is superior to the other colonoscopy methods (Water/Air, CO2/CO2, Air/Air).

Enrollment: 420 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• men and women older than 18 years referred for diagnostic outpatient colonoscopy
• provided written consent

Exclusion criteria

• history of colorectal surgery
• known diagnosis of inflammatory bowel disease
• chronic benzodiazepine use
• refusal of minimal sedation

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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420 participants in 4 patient groups

Water/CO2

Experimental group

Description:

water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal

Treatment:

Procedure: Water immersion insertion AND CO2 insufflation

Water/Air

Experimental group

Description:

Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal

Treatment:

Procedure: Water immersion insertion

CO2/CO2

Experimental group

Description:

CO2 insufflation during both colonoscope insertion and withdrawal

Treatment:

Procedure: CO2 insufflation

Air/Air

No Intervention group

Description:

room air insufflation during both colonoscope insertion and withdrawal