Clinical trial NCT01076907: Techniques to Enhance Patient Comfort in Sedation-risk Free Colonoscopy
Official title: Can Simple and Inexpensive Techniques Enhance Patient Comfort in Sedation-risk Free Screening and Surveillance Colonoscopy?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Screening of Colonic Polyps
Keywords: colonoscopy
polyps
Lead sponsor: VA Greater Los Angeles Healthcare System
Sponsor class: FED
First posted: 2010-02-26
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: abdominal discomfort
timeFrame: 30 days
Secondary outcomes:
measure: colonoscopy-related outcomes
timeFrame: 30 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Greater Los Angeles Healthcare System and the Sepulveda Ambulatory Care Center
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System
name: Felix W. Leung, MD
role: PRINCIPAL_INVESTIGATOR
References: