Techniques to Enhance Patient Comfort in Sedation-risk Free Colonoscopy

Screening of Colonic Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01076907
• Other study ID #: FL0055
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: February 25, 2010
• Last updated: December 14, 2015
• Start date: December 2007
• Est. completion date: June 2011

Study information

• Verified date: December 2015
• Source: VA Greater Los Angeles Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 85
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colonic Polyps
• Screening of Colonic Polyps

Intervention

Other:
• Warm water
Warm water loading of sigmoid colon when spasms occur and waiting for them to subside.
• Control
Air will be used instead of warm water for unsedated colonoscopy.

Locations

Country	Name	City	State
United States	Greater Los Angeles Healthcare System and the Sepulveda Ambulatory Care Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Greater Los Angeles Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	abdominal discomfort	Abdominal discomfort reported to a blinded observer 5-10 min after colonoscopy.	30 days	No
Secondary	colonoscopy-related outcomes	various procedure related measures	30 days	No