Warm Water and Unsedated Colonoscopy
WW
Warm Water Colonoscopy: a Novel Method for Unsedated Colonoscopy
1 other identifier
interventional
818
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Nov 2011
Shorter than P25 for early_phase_1
2 active sites
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
First Submitted
Initial submission to the registry
October 25, 2011
CompletedFirst Posted
Study publicly available on registry
November 1, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedFebruary 8, 2013
February 1, 2013
10 months
October 25, 2011
February 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
evaluation of pain and tolerability scores
1 hour
percentage of caecum intubation
1 hour
time to reach caecum
1 hour
Adenoma detection rate
9 months
Study Arms (2)
warm water irrigation
EXPERIMENTALwarm water irrigation during insertion phase of colonoscopy
air insufflation
EXPERIMENTALair insufflation during insertion phase of colonoscopy
Interventions
warm water irrigation during insertion phase colonoscopy
Eligibility Criteria
You may qualify if:
- Years to 85 Years
- adult patients 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
Study Sites (2)
Servizio Endoscopia Digestiva
Iglesias, Carbonia-Iglesias, 09016, Italy
U.O.S.D. Diagnostica e Terapia Endoscopica
San Gavino Monreale, Medio Campidano (VS), 09037, Italy
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Sergio Cadoni, M.D.
A.S.L. 07 Sardegna
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Responsabile Servizio Endoscopia Digestiva
Study Record Dates
First Submitted
October 25, 2011
First Posted
November 1, 2011
Study Start
November 1, 2011
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
February 8, 2013
Record last verified: 2013-02