Warm Water and Unsedated Colonoscopy (WW)

Warm Water Colonoscopy: a Novel Method for Unsedated Colonoscopy

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.

Study Overview

• Status: Completed
• Conditions: Digestive System Diseases; Gastrointestinal Diseases
• Intervention / Treatment: Other: warm water irrigation; Other: air insufflation

• Study Type: Interventional
• Enrollment (Actual): 818
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Italy
  • Carbonia-Iglesias
    • Iglesias, Carbonia-Iglesias, Italy, 09016
      • Servizio Endoscopia Digestiva
  • Medio Campidano (VS)
    • San Gavino Monreale, Medio Campidano (VS), Italy, 09037
      • U.O.S.D. Diagnostica e Terapia Endoscopica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: warm water irrigation; warm water irrigation during insertion phase of colonoscopy	Other: warm water irrigation; warm water irrigation during insertion phase colonoscopy
Experimental: air insufflation; air insufflation during insertion phase of colonoscopy	Other: air insufflation; air insufflation during insertion phase colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Presidio Ospedaliero Santa Barbara
• Investigators: Principal Investigator: Sergio Cadoni, M.D., A.S.L. 07 Sardegna

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: October 25, 2011
• First Submitted That Met QC Criteria: October 28, 2011
• First Posted (Estimate): November 1, 2011

Study Record Updates

• Last Update Posted (Estimate): February 8, 2013
• Last Update Submitted That Met QC Criteria: February 7, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: colonoscopy; unsedated colonoscopy; warm water method; hydrocolonoscopy
• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: ASL07_WW-2011