Techniques to Enhance Patient Comfort in Sedation-risk Free Colonoscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Can Simple and Inexpensive Techniques Enhance Patient Comfort in Sedation-risk Free Screening and Surveillance Colonoscopy?

Conditions
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Screening of Colonic Polyps

Intervention / Treatment
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* Other: Warm water
* Other: Control


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Warm water loading of sigmoid colon<br>Warm water loading of sigmoid colon and irrigation when spasms occur. | Other: Warm water<br>* Warm water loading of sigmoid colon when spasms occur and waiting for them to subside.<br>|
| Placebo Comparator: Control<br>No water loading, only air and waiting for spasms to subside. | Other: Control<br>* Air will be used instead of warm water for unsedated colonoscopy.<br>* Other names: air;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| abdominal discomfort | Abdominal discomfort reported to a blinded observer 5-10 min after colonoscopy. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| colonoscopy-related outcomes | various procedure related measures | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, polyps