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Warm Water and Unsedated Colonoscopy

NCT01463319 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 818

Last updated 2013-02-08

No results posted yet for this study

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.

Conditions

  • Gastrointestinal Diseases
  • Digestive System Diseases

Interventions

OTHER

air insufflation

air insufflation during insertion phase colonoscopy

OTHER

warm water irrigation

warm water irrigation during insertion phase colonoscopy

Sponsors & Collaborators

  • Presidio Ospedaliero Santa Barbara

    lead OTHER

Principal Investigators

  • Sergio Cadoni, M.D. · A.S.L. 07 Sardegna

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01463319 on ClinicalTrials.gov