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Techniques to Enhance Patient Comfort in Sedation-risk Free Colonoscopy

Primary Purpose

Screening of Colonic Polyps

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Warm water
Control
Sponsored by
VA Greater Los Angeles Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Screening of Colonic Polyps focused on measuring colonoscopy, polyps

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Greater Los Angeles Healthcare System and the Sepulveda Ambulatory Care Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Warm water loading of sigmoid colon

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

abdominal discomfort
Abdominal discomfort reported to a blinded observer 5-10 min after colonoscopy.

Secondary Outcome Measures

colonoscopy-related outcomes
various procedure related measures

Full Information

First Posted
February 25, 2010
Last Updated
December 14, 2015
Sponsor
VA Greater Los Angeles Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT01076907
Brief Title
Techniques to Enhance Patient Comfort in Sedation-risk Free Colonoscopy
Official Title
Can Simple and Inexpensive Techniques Enhance Patient Comfort in Sedation-risk Free Screening and Surveillance Colonoscopy?
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
Necessary equipment to perform the study arms was removed by the medical center administration.
Study Start Date
December 2007 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Greater Los Angeles Healthcare System

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Hypotheses 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 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Screening of Colonic Polyps
Keywords
colonoscopy, polyps

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Warm water loading of sigmoid colon
Arm Type
Experimental
Arm Description
Warm water loading of sigmoid colon and irrigation when spasms occur.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
No water loading, only air and waiting for spasms to subside.
Intervention Type
Other
Intervention Name(s)
Warm water
Intervention Description
Warm water loading of sigmoid colon when spasms occur and waiting for them to subside.
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
air
Intervention Description
Air will be used instead of warm water for unsedated colonoscopy.
Primary Outcome Measure Information:
Title
abdominal discomfort
Description
Abdominal discomfort reported to a blinded observer 5-10 min after colonoscopy.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
colonoscopy-related outcomes
Description
various procedure related measures
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felix W. Leung, MD
Organizational Affiliation
VA Greater Los Angeles Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Greater Los Angeles Healthcare System and the Sepulveda Ambulatory Care Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
91343
Country
United States

12. IPD Sharing Statement

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Techniques to Enhance Patient Comfort in Sedation-risk Free Colonoscopy

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