Techniques to Enhance Patient Comfort in Sedation-risk Fr... | NCT01076907

Studies
Techniques to Enhance Patient Comfort in Sedation-risk Free Colonoscopy

NCT01076907

Sponsor

VA Greater Los Angeles Healthcare System

Status

Terminated

Last Update Posted

Dec 15, 2015Estimated

Enrollment

85Actual

Phase

Phase 1Phase 2

Conditions

Screening of Colonic Polyps

Interventions

Warm water
Control

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Necessary equipment to perform the study arms was removed by the medical center administration.

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Feb 25, 2010

First Submission Date that Met QC Criteria

Feb 25, 2010

First Posted Date

Feb 26, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2015

Last Update Posted Date

Dec 15, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Felix W. Leung, Staff Physician, VA Greater Los Angeles Healthcare SystemPrincipal Investigator

Lead Sponsor

VA Greater Los Angeles Healthcare SystemFED

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Hypotheses

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
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

85Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Warm water loading of sigmoid colon	Experimental	Warm water loading of sigmoid colon and irrigation when spasms occur.	Other: Warm water
Control	Placebo Comparator	No water loading, only air and waiting for spasms to subside.	Other: Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Warm water	Other	Warm water loading of sigmoid colon when spasms occur and waiting for them to subside.	Warm water loading of sigmoid colon

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
abdominal discomfort	Abdominal discomfort reported to a blinded observer 5-10 min after colonoscopy.	30 days

Secondary Outcomes

Measure	Description	Time Frame
colonoscopy-related outcomes	various procedure related measures	30 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Felix W. Leung, MD	VA Greater Los Angeles Healthcare System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Greater Los Angeles Healthcare System and the Sepulveda Ambulatory Care Center		Los Angeles	California	91343	United States

Condition Browse Module

MeSH Terms

ID	Term
D011127	Polyps

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000388	Air

Ancestor Terms

ID	Term
D001272	Atmosphere
D004777	Environment
D055669	Ecological and Environmental Phenomena
D001686	Biological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided