Techniques to Enhance Patient Comfort in Sedation-risk Free Colonoscopy

Phase 1

Terminated

• Conditions: Screening of Colonic Polyps
• Interventions: Other: Warm water; Other: Control

• Registration Number: NCT01076907
• Lead Sponsor: VA Greater Los Angeles Healthcare System

Brief 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.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2010-02-25
• Study First Submitted QC: 2010-02-25
• Study First Posted: 2010-02-26
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-14
• Last Update Posted: 2015-12-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 85

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Warm water loading of sigmoid colon	Warm water	Warm water loading of sigmoid colon and irrigation when spasms occur.
Control	Control	No water loading, only air and waiting for spasms to subside.

Primary Outcome Measures

Name	Time	Method
abdominal discomfort	30 days	Abdominal discomfort reported to a blinded observer 5-10 min after colonoscopy.

Secondary Outcome Measures

Name	Time	Method
colonoscopy-related outcomes	30 days	various procedure related measures

Trial Locations

Locations (1)

Greater Los Angeles Healthcare System and the Sepulveda Ambulatory Care Center; 🇺🇸 Los Angeles, California, United States