Warm Water Versus Room Temperature Water Immersion Colonoscopy

Colorectal Cancer Clinical Trial

Official title:

Warm Water Versus Room Temperature Water Immersion Colonoscopy - a Prospective, Randomized, Double-blind, Single-center Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01582178
• Other study ID #: DDC VN 04
• Status: Completed
• Phase: N/A
• First received: April 18, 2012
• Last updated: September 19, 2013
• Start date: June 2012
• Est. completion date: October 2012

Study information

• Verified date: September 2013
• 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. There was used warm water infusion for colonoscope insertion in most of the water immersion colonoscopy trials.

The investigators have been using room temperature water (20-24°C) for water immersion and the investigators did not notice any drawback of it. In our opinion, it is simpler and cheaper option for water immersion colonoscopy and proof of its efficacy and safety could support the use of water immersion technique in routine practice.

The primary endpoint is cecal intubation time and the investigators suppose that the use of warm water infusion does not 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 will be also assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: October 2012
• Est. primary completion date: October 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: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Procedure:
• Warm Water Immersion Colonoscopy
Colonoscopy using warm water (37°C) infusion for colonoscope insertion and room air insufflation during colonoscope withdrawal.
• Cool Water Immersion Colonoscopy
Colonoscopy using room temperature water (20-24°C) infusion for colonoscope insertion and room 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, Tvrdík J, Urban O. Cool water vs warm water immersion for minimal sedation colonoscopy: a double-blind randomized trial. Colorectal Dis. 2013;15(10):e612-7. doi: 10.1111/codi.12336. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cecal Intubation Time		3 months	Yes
Primary	Cecal Intubation Time	= time between introduction of the colonoscope into the anus and reaching the cecum.	1-30	No
Secondary	Patient Comfort During Insertion Phase of the Colonoscopy		3 months	No