Warm Water for Unsedated Colonoscopy
WW
Warm Water Irrigation Versus Standard Air Insufflation for Unsedated Colonoscopy: a Randomized Controlled Trial
1 other identifier
interventional
230
1 country
1
Brief Summary
Unsedated colonoscopy is characterized by lower costs, recovery time and incidence of drug-related side effects, although it may be painful for the patient. Based on recent reports, the investigators designed this randomized controlled trial hypothesizing that the use of 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2009
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 15, 2009
CompletedFirst Posted
Study publicly available on registry
May 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
October 25, 2011
CompletedOctober 25, 2011
September 1, 2011
3 months
May 15, 2009
August 5, 2011
September 15, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Patients Undergoing Complete Unsedated Colonoscopy
6-9 months
Secondary Outcomes (1)
Evaluation of Pain and Tolerability Scores
6-9 months
Study Arms (2)
warm water
EXPERIMENTALwarm water irrigation during the insertion phase of colonoscopy
air
ACTIVE COMPARATORair insufflation during the insertion phase of colonoscopy
Interventions
Eligibility Criteria
You may qualify if:
- adult outpatients willing to undergo colonoscopy without routine initial sedation
You may not qualify if:
- refuse to initiate colonoscopy without routine sedation
- inadequate bowel preparation
- incapacity to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Valduce Hospitallead
Study Sites (1)
Valduce Hospital
Como, CO, 22100, Italy
Related Publications (1)
Radaelli F, Paggi S, Amato A, Terruzzi V. Warm water infusion versus air insufflation for unsedated colonoscopy: a randomized, controlled trial. Gastrointest Endosc. 2010 Oct;72(4):701-9. doi: 10.1016/j.gie.2010.06.025.
PMID: 20883846DERIVED
Results Point of Contact
- Title
- Vittorio Terruzzi, MD
- Organization
- Valduce Hospital - Como - Italy
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 15, 2009
First Posted
May 20, 2009
Study Start
April 1, 2009
Primary Completion
July 1, 2009
Study Completion
February 1, 2010
Last Updated
October 25, 2011
Results First Posted
October 25, 2011
Record last verified: 2011-09