Cap-assisted Water Immersion Versus Water Immersion Colonoscopy

Colonoscopy Clinical Trial

Official title:

Cap-assisted Water Immersion Versus Water Immersion Minimal Sedation Colonoscopy - a Prospective, Randomized, Single-center Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01547247
• Other study ID #: DDC VN 03
• Status: Completed
• Phase: N/A
• First received: February 26, 2012
• Last updated: October 4, 2015
• Start date: January 2012
• Est. completion date: June 2012

Study information

• Verified date: October 2015
• Source: Vitkovice Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Device:
• 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.

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

Locations

Country	Name	City	State
Czech Republic	Digestive Diseases Center, Vitkovice Hospital	Ostrava

Sponsors (1)

Lead Sponsor	Collaborator
Vitkovice Hospital

Country where clinical trial is conducted

Czech Republic, 

References & Publications (1)

Falt P, Šmajstrla V, Fojtík P, Liberda M, Kliment M, Tvrdík 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. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cecal Intubation Time	The primary endpoint (cecal intubation time) was defined as a time between introduction of the colonoscope into the anus and reaching the cecum.	3 months	Yes
Secondary	Patient Comfort During Insertion Phase of the Colonoscopy		3 months	No
Secondary	Success Rate of Minimal Sedation Colonoscopy	A successful minimal sedation colonoscopy was defined as reaching the cecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam.	3 months	No