Warm Water and Unsedated Colonoscopy

Warm Water Colonoscopy: a Novel Method for Unsedated Colonoscopy

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01463319

Acronym

Enrollment

818

Registered

2011-11-01

Start date

2011-11-30

Completion date

2012-09-30

Last updated

2013-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Diseases, Digestive System Diseases

Keywords

colonoscopy, warm water method, hydrocolonoscopy, unsedated colonoscopy

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.

Interventions

OTHERwarm water irrigation

warm water irrigation during insertion phase colonoscopy

OTHERair insufflation

air insufflation during insertion phase colonoscopy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
percentage of caecum intubation	1 hour	—
time to reach caecum	1 hour	—
Adenoma detection rate	9 months	Proportion of patients with at least one adenoma of any size

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026