NCT01076907

Techniques to Enhance Patient Comfort in Sedation-risk Free Colonoscopy

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: VA Greater Los Angeles Healthcare System · Federal
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Screening of Colonic Polyps

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-12-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-02-26
• Last updated: 2015-12-15

Locations

1 site across 1 country: United States