Techniques to Enhance Patient Comfort in Sedation-risk Free Colonoscopy

VA Greater Los Angeles Healthcare System

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Screening of Colonic Polyps

Treatments: Other: Warm water; Other: Control

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01076907

FL0055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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85 participants in 2 patient groups, including a placebo group

Warm water loading of sigmoid colon

Experimental group

Description:

Warm water loading of sigmoid colon and irrigation when spasms occur.

Treatment:

Other: Warm water

Control

Placebo Comparator group

Description:

No water loading, only air and waiting for spasms to subside.

Treatment:

Other: Control