Combination of Water Immersion and Carbon Dioxide Insufflation for Minimal Sedation Colonoscopy (Water/CO2)

Combination of Water Immersion and Carbon Dioxide Insufflation for Minimal Sedation Colonoscopy - a Prospective, Randomized, Single-center Trial

Water immersion insertion and carbon dioxide (CO2)instead of room air insufflation as alternative colonoscopy techniques have been documented to decrease patient discomfort during and after the procedure.

This prospective, randomized, single-center trial was designed to evaluate whether the combination of water immersion during insertion and CO2 insufflation during withdrawal (Water/CO2)for minimal sedation colonoscopy (2 mg of midazolam i.v.)is superior to the other colonoscopy methods (Water/Air, CO2/CO2, Air/Air).

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Procedure: Water immersion insertion AND CO2 insufflation; Procedure: Water immersion insertion; Procedure: CO2 insufflation

• Study Type: Interventional
• Enrollment (Actual): 420
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czech Republic
  • Ostrava, Czech Republic, 703 84
    • Digestive Diseases Center - Vitkovice 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:

• men and women older than 18 years referred for diagnostic outpatient colonoscopy
• provided written consent

Exclusion Criteria:

• history of colorectal surgery
• known diagnosis of inflammatory bowel disease
• chronic benzodiazepine use
• refusal of minimal sedation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Water/CO2; water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal	Procedure: Water immersion insertion AND CO2 insufflation; room temperature water infused by water pump into the colon just to facilitate scope insertion; CO2 insufflation by CO2 insufflation system during colonoscope withdrawal and mucosal inspection
Experimental: Water/Air; Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal	Procedure: Water immersion insertion; room temperature water infused by water pump into the colon just to facilitate scope insertion; standard room air insufflation during colonoscope withdrawal and mucosal inspection
Experimental: CO2/CO2; CO2 insufflation during both colonoscope insertion and withdrawal	Procedure: CO2 insufflation; - CO2 insufflation by CO2 insufflation system during both colonoscope insertion and withdrawal
No Intervention: Air/Air; room air insufflation during both colonoscope insertion and withdrawal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success Rate of Minimal Sedation Colonoscopy	Successful minimal sedation colonoscopy using assigned technique was defined as reaching the caecum without switch to another insertion method and / or without additional sedation beyond the initial administration of 2 mg of midazolam.	six months
Success Rate of Minimal Sedation Colonoscopy	A succesful colonoscopy using assigned technique was defined as reaching the caecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam. Any time the further insertion of the scope was not possible, the patient reported pain level > 3 using a 7-point Likert scale [7] (0 = no pain, 6 = intolerable pain) or demanded additional sedation, the endoscopist preferentially switched to the other insertion technique. Enhanced sedation was used in case the other technique had not been successful.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Comfort During the Procedure and During First 24 Hours After Procedure	Comfort was assessed using a 18-point questionnaire form based on 0-6 continuous scale (0 = best, 6 = worst)- abdominal pain during, 30 minutes, 3, 12 and 24 hours after the procedure, bloating duringm 30 minutes, 3, 12 and 24 hours after the procedure, flatus during, 30 minutes, 3, 12 and 24 hours after the procedure, impact on patient´s daily activities during first 24 hours after the procedure, willingnes to repeat the colonoscopy and overall satisfaction with the procedure	six months

Collaborators and Investigators

• Sponsor: Vitkovice Hospital
• Investigators: Principal Investigator: Premysl Falt, MD, Digestive Diseases Center, Vitkovice Hospital, Ostrava, Czech Republic

Publications and helpful links

General Publications

• Falt P, Liberda M, Smajstrla V, Kliment M, Bartkova A, Tvrdik J, Fojtik P, Urban O. Combination of water immersion and carbon dioxide insufflation for minimal sedation colonoscopy: a prospective, randomized, single-center trial. Eur J Gastroenterol Hepatol. 2012 Aug;24(8):971-7. doi: 10.1097/MEG.0b013e3283543f16.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: September 19, 2011
• First Submitted That Met QC Criteria: September 22, 2011
• First Posted (Estimate): September 26, 2011

Study Record Updates

• Last Update Posted (Estimate): January 28, 2013
• Last Update Submitted That Met QC Criteria: December 20, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: colonoscopy; CO2 insufflation; water immersion; patients referred for diagnostic outpatient colonoscopy; (screening, surveillance, symptoms); patient discomfort associated with diagnostic colonoscopy
• Other Study ID Numbers: DDC VN 01