Warm Water Versus Room Temperature Water Immersion Colonoscopy

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: Warm Water Immersion Colonoscopy; Procedure: Cool Water Immersion Colonoscopy

• Study Type: Interventional
• Enrollment (Actual): 212
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czech Republic
  • Ostrava, Czech Republic, 703 84
    • Digestive Diseases Center, Vìtkovice Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Warm Water Immersion Colonoscopy; Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.	Procedure: Warm Water Immersion Colonoscopy; Colonoscopy using warm water (37°C) infusion for colonoscope insertion and room air insufflation during colonoscope withdrawal.
ACTIVE_COMPARATOR: Cool Water Immersion Colonoscopy; Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.	Procedure: Cool Water Immersion Colonoscopy; Colonoscopy using room temperature water (20-24°C) infusion for colonoscope insertion and room air insufflation during colonoscope withdrawal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cecal Intubation Time		3 months
Cecal Intubation Time	= time between introduction of the colonoscope into the anus and reaching the cecum.	1-30

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient Comfort During Insertion Phase of the Colonoscopy	3 months

Collaborators and Investigators

• Sponsor: Vitkovice Hospital

Publications and helpful links

General Publications

• Falt P, Smajstrla V, Fojtik P, Tvrdik 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: April 18, 2012
• First Submitted That Met QC Criteria: April 19, 2012
• First Posted (ESTIMATE): April 20, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): September 20, 2013
• Last Update Submitted That Met QC Criteria: September 19, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: colonoscopy; warm water immersion; cool water immersion
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: DDC VN 04