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

NCT01440543 | Completed Results

• 1 other identifier: DDC VN 01
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Colonoscopy

Keywords

colonoscopy; water immersion; CO2 insufflation; patients referred for diagnostic outpatient colonoscopy; (screening, surveillance, symptoms); patient discomfort associated with diagnostic colonoscopy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Patient Comfort During the Procedure and During First 24 Hours After Procedure

  six months

Study Arms (4)

Water/CO2

EXPERIMENTAL

water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal

Procedure: Water immersion insertion AND CO2 insufflation

Water/Air

EXPERIMENTAL

Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal

Procedure: Water immersion insertion

CO2/CO2

EXPERIMENTAL

CO2 insufflation during both colonoscope insertion and withdrawal

Procedure: CO2 insufflation

Air/Air

NO INTERVENTION

room air insufflation during both colonoscope insertion and withdrawal

Interventions

Water immersion insertion AND CO2 insufflation PROCEDURE

* 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/CO2

Water immersion insertion PROCEDURE

* 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

Water/Air

CO2 insufflation PROCEDURE

\- CO2 insufflation by CO2 insufflation system during both colonoscope insertion and withdrawal

CO2/CO2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vitkovice Hospital: lead

Study Sites (1)

Digestive Diseases Center - Vitkovice Hospital

Ostrava, 703 84, Czechia

Location

Related Publications (1)

• 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.

  PMID: 22569079 RESULT

Limitations and Caveats

There were no procedure- or sedation-related complications recorded in the study.

Results Point of Contact

• Title: Premysl Falt MD
• Organization: Digestive Diseases Center, Vitkovice Hospital, Ostrava, Czech Republic

faltprem@centrum.cz

+420602689561

Study Officials

• Premysl Falt, MD

  Digestive Diseases Center, Vitkovice Hospital, Ostrava, Czech Republic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: September 26, 2011
• Study Start: January 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 28, 2013
• Results First Posted: January 28, 2013

Record last verified: 2012-12

Locations

CZ (1)