Cap-assisted Water Immersion Versus Water Immersion Colonoscopy

NCT ID: NCT01547247

Last Updated: 2015-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-06-30

Brief 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.

Conditions

Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

cap-assisted water immersion colonoscopy

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Colonoscopy with transparent cap attached to the tip of the colonoscope and water immersion during insertion phase and romm air insufflation during colonoscope withdrawal.

water immersion colonoscopy

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

Group Type: ACTIVE_COMPARATOR

water immersion colonoscopy

Intervention Type: PROCEDURE

Colonoscopy without transparent cap using water immersion during insertion phase and romm air insufflation during colonoscope withdrawal.

Interventions

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

Colonoscopy with transparent cap attached to the tip of the colonoscope and water immersion during insertion phase and romm air insufflation during colonoscope withdrawal.

Intervention Type: DEVICE

water immersion colonoscopy

Colonoscopy without transparent cap using water immersion during insertion phase and romm air insufflation during colonoscope withdrawal.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vitkovice Hospital

OTHER

Sponsor Role: lead

Responsible Party

Premysl Falt MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Premysl Falt, MD

Role: PRINCIPAL_INVESTIGATOR

Digestive Diseases Center, Vitkovice Hospital

Locations

Digestive Diseases Center, Vitkovice Hospital

Ostrava, , Czechia

Countries

Czechia

References

Falt P, Smajstrla V, Fojtik P, Liberda M, Kliment M, Tvrdik J, Urban O. Cap-assisted water immersion for minimal sedation colonoscopy: prospective, randomized, single-center trial. Dig Endosc. 2013 Jul;25(4):434-9. doi: 10.1111/j.1443-1661.2012.01402.x. Epub 2012 Dec 5.

Reference Type: RESULT

PMID: 23808948 (View on PubMed)

Other Identifiers

DDC VN 03

Identifier Type: -

Identifier Source: org_study_id