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Techniques to Enhance Patient Comfort in Sedation-risk Free Colonoscopy

NCT01076907 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2015-12-15

No results posted yet for this study

Summary

Hypotheses

1. Loading the sigmoid colon with warm water and warm water irrigation for dealing with spasm (Study Treatment) will significantly reduce the proportion of patients complaining of abdominal discomfort compared with no water loading and waiting for spasms to subside (Control Treatment). The median discomfort score reported by the patients will be significantly lower in the group receiving the Study Treatment than the group receiving Control Treatment. Hypothesis
2. Exploratory hypothesis: There are differences in secondary outcome variables when patients managed by the Study and Control Treatments are compared. Co-variables affect the primary and secondary outcome variables.

Conditions

  • Screening of Colonic Polyps

Interventions

OTHER

Warm water

Warm water loading of sigmoid colon when spasms occur and waiting for them to subside.

OTHER

Control

Air will be used instead of warm water for unsedated colonoscopy.

Sponsors & Collaborators

  • VA Greater Los Angeles Healthcare System

    lead FED

Principal Investigators

  • Felix W. Leung, MD · VA Greater Los Angeles Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States

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 NCT01076907 on ClinicalTrials.gov