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Techniques to Enhance Patient Comfort in Sedation-risk Free Colonoscopy

NCT ID: NCT01076907

Last Updated: 2015-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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The purpose of the study is to conduct a RCT study to determine the effectiveness of loading the sigmoid colon with warm water and warm water irrigation for dealing with colonic spasms in enhancing patient abdominal comfort during unsedated colonoscopy. The specific aim is to compare Study Treatment of warm water loading and irrigation when spasms occur with Control Treatment of no water loading and waiting for spasms to subside. The proportion of patients complaining of abdominal discomfort and their discomfort score are the primary outcome variables. The secondary outcome variables and co-variables described below will be recorded in a prospective manner to ensure completeness of data collection. In preliminary clinical observation at VA Sepulveda ACC, 25 to 30% of VA patients accept colonoscopy without sedation. The goal of this study is to find ways of further reducing discomfort associated with unsedated colonoscopy.

Conditions

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Screening of Colonic Polyps

Keywords

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colonoscopy polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Warm water loading of sigmoid colon

Warm water loading of sigmoid colon and irrigation when spasms occur.

Group Type EXPERIMENTAL

Warm water

Intervention Type OTHER

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

Control

No water loading, only air and waiting for spasms to subside.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

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

Interventions

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Warm water

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

Intervention Type OTHER

Control

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

Intervention Type OTHER

Other Intervention Names

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air

Eligibility Criteria

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Inclusion Criteria

* Accepts adult healthy male and female patients
* At least 18 years of age
* In need of colonoscopy for screening or follow up of colonic polyps
* Willing to consent and be randomized

Exclusion Criteria

* Patients receiving outpatient narcotic treatment
* Patients who report excessive anxiety
* Patients with moderate to severe abdominal discomfort
* Unable to provide consent
* Have poor bowel preparation
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Greater Los Angeles Healthcare System

FED

Sponsor Role lead

Responsible Party

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Felix W. Leung

Staff Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Felix W. Leung, MD

Role: PRINCIPAL_INVESTIGATOR

VA Greater Los Angeles Healthcare System

Locations

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Greater Los Angeles Healthcare System and the Sepulveda Ambulatory Care Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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FL0055

Identifier Type: -

Identifier Source: org_study_id