Warm Water and Unsedated Colonoscopy

Early Phase 1

Completed

• Conditions: Gastrointestinal Diseases; Digestive System Diseases
• Interventions: Other: warm water irrigation; Other: air insufflation

• Registration Number: NCT01463319
• Lead Sponsor: Presidio Ospedaliero Santa Barbara

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-25
• Study First Submitted QC: 2011-10-28
• Study Start: 2011-11
• Study First Posted: 2011-11-01
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-07
• Last Update Posted: 2013-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 818

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
warm water irrigation	warm water irrigation	warm water irrigation during insertion phase of colonoscopy
air insufflation	air insufflation	air insufflation during insertion phase of colonoscopy

Primary Outcome Measures

Name	Time	Method
number of patients undergoing complete unsedated or slightly sedated colonoscopy	9 months	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.

Secondary Outcome Measures

Name	Time	Method
time to reach caecum	1 hour
percentage of caecum intubation	1 hour
Adenoma detection rate	9 months	Proportion of patients with at least one adenoma of any size
evaluation of pain and tolerability scores	1 hour	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.

Trial Locations

Locations (2)

Servizio Endoscopia Digestiva; 🇮🇹 Iglesias, Carbonia-Iglesias, Italy

U.O.S.D. Diagnostica e Terapia Endoscopica; 🇮🇹 San Gavino Monreale, Medio Campidano (VS), Italy