Combination of Water Immersion and Carbon Dioxide Insufflation for Minimal Sedation Colonoscopy

Colonoscopy Clinical Trial

— Water/CO2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440543
• Other study ID #: DDC VN 01
• Status: Completed
• Phase: N/A
• First received: September 19, 2011
• Last updated: December 20, 2012
• Start date: January 2011
• Est. completion date: September 2011

Study information

• Verified date: December 2012
• Source: Vitkovice Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: September 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Colonoscopy

Intervention

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
• 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
• CO2 insufflation
- CO2 insufflation by CO2 insufflation system during both colonoscope insertion and 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, Liberda M, Smajstrla V, Kliment M, Bártková A, Tvrdík J, Fojtík P, Urban O. Combination of water immersion and carbon dioxide insufflation for minimal sedation colonoscopy: a prospective, randomized, single-center trial. Eur J Gastroenterol Hepato — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Secondary	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	No