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?

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.

Study Overview

• Status: Terminated
• Conditions: Screening of Colonic Polyps
• Intervention / Treatment: Other: Warm water; Other: Control

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 Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 91343
      • Greater Los Angeles Healthcare System and the Sepulveda Ambulatory Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: VA Greater Los Angeles Healthcare System
• Investigators: Principal Investigator: Felix W. Leung, MD, VA Greater Los Angeles Healthcare System

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: February 25, 2010
• First Submitted That Met QC Criteria: February 25, 2010
• First Posted (Estimate): February 26, 2010

Study Record Updates

• Last Update Posted (Estimate): December 15, 2015
• Last Update Submitted That Met QC Criteria: December 14, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: polyps; colonoscopy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Colonic Polyps
• Other Study ID Numbers: FL0055