Warm Water Versus Room Temperature Water Immersion Colonoscopy

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Procedure: Warm Water Immersion Colonoscopy; Procedure: Cool Water Immersion Colonoscopy

• Registration Number: NCT01582178
• Lead Sponsor: Vitkovice Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-18
• Study First Submitted QC: 2012-04-19
• Study First Posted: 2012-04-20
• Study Start: 2012-06
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Results First Submitted: 2013-06-02
• Results First Submitted QC: 2013-06-02
• Results First Posted: 2013-08-01
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-19
• Last Update Posted: 2013-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 212

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Warm Water Immersion Colonoscopy	Warm Water Immersion Colonoscopy	Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
Cool Water Immersion Colonoscopy	Cool Water Immersion Colonoscopy	Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.

Primary Outcome Measures

Name	Time	Method
Cecal Intubation Time	1-30	= time between introduction of the colonoscope into the anus and reaching the cecum.

Secondary Outcome Measures

Name	Time	Method
Patient Comfort During Insertion Phase of the Colonoscopy	3 months

Trial Locations

Locations (1)

Digestive Diseases Center, Vitkovice Hospital; 🇨🇿 Ostrava, Czech Republic