Warm Water and Unsedated Colonoscopy

Gastrointestinal Diseases Clinical Trial

— WW  

Official title:

Warm Water Colonoscopy: a Novel Method for Unsedated Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463319
• Other study ID #: ASL07_WW-2011
• Status: Completed
• Phase: Phase 0
• First received: October 25, 2011
• Last updated: February 7, 2013
• Start date: November 2011
• Est. completion date: September 2012

Study information

• Verified date: February 2013
• Source: Presidio Ospedaliero Santa Barbara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Unsedated or slightly sedated colonoscopy has fast recovery time, less cost and lower or no incidence of drug-related side effects. May be slightly painful or discomforting for the patient. Based on numerous recent reports, the investigators designed this randomized controlled trial hypothesizing that the use of warm water irrigation versus air insufflation during the insertion phase of colonoscopy might increase the global tolerability of the examination and the proportion of patients undergoing complete colonoscopy without sedation or with a low dose of sedatives.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 818
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 18 Years to 85 Years

• adult patients willing to undergo colonoscopy without routine initial sedation

Exclusion Criteria:

• refuse to initiate colonoscopy without routine sedation

• inadequate bowel preparation

• incapacity to give informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases

Intervention

Other:
• air insufflation
air insufflation during insertion phase colonoscopy
• warm water irrigation
warm water irrigation during insertion phase colonoscopy

Locations

Country	Name	City	State
Italy	Servizio Endoscopia Digestiva	Iglesias	Carbonia-Iglesias
Italy	U.O.S.D. Diagnostica e Terapia Endoscopica	San Gavino Monreale	Medio Campidano (VS)

Sponsors (1)

Lead Sponsor	Collaborator
Presidio Ospedaliero Santa Barbara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients undergoing complete unsedated or slightly sedated colonoscopy	number of patients undergoing complete unsedated conoloscopy with a pain score (as per used scale) =2, or patients with no more than that score AND =2 mg Midazolam E.V.	9 months	No
Secondary	evaluation of pain and tolerability scores	Numeric rating scale, Verbal Descriptor Scale and Faces Pain Scale (0= no pain, 10 worst possible pain.) Hicks CL et al. Pain 2001;93:173-183. Bieri D. et al. Pain. 1990;41(2):138-50.	1 hour	No
Secondary	percentage of caecum intubation		1 hour	No
Secondary	time to reach caecum		1 hour	No
Secondary	Adenoma detection rate	Proportion of patients with at least one adenoma of any size	9 months	No