Comparing Warm Versus Cool Temperature Water During Colon... | NCT01322724

Studies
Comparing Warm Versus Cool Temperature Water During Colonoscopy

NCT01322724

Sponsor

OHSU Knight Cancer Institute

Status

Completed

Last Update Posted

May 25, 2012Estimated

Enrollment

175Actual

Phase

Not Applicable

Conditions

Colonoscopy

Interventions

Warm vs Cool water

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

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Apr 2012Actual

Completion Date

Apr 2012Actual

First Submitted Date

Mar 24, 2011

First Submission Date that Met QC Criteria

Mar 24, 2011

First Posted Date

Mar 25, 2011Estimated

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

May 24, 2012

Last Update Posted Date

May 25, 2012Estimated

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

The purpose of this study will be to determine if the temperature of water used during insertion of colonoscopy makes a difference in patient discomfort and sedation requirements. The hypothesis of this study is patients receiving screening colonoscopy utilizing the water insertion method with room temperature (cool) water will have similar pain scores and medication requirements compared to water insertion method using body temperature (warm) water.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

175Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Warm water	Active Comparator	Body temperature (95-100 degrees F) water	Procedure: Warm vs Cool water
Cool water	Experimental	Room temperature (68-73 degrees F) water	Procedure: Warm vs Cool water

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Warm vs Cool water	Procedure	Body vs Room temperature water used during insertion of colonoscopy	Cool water Warm water

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dose of sedation medication used (fentanyl and midazolam)		Duration of the colonoscopy; Up to 3 hours

Secondary Outcomes

Measure	Description	Time Frame
Patient pain/discomfort score		During the day of the procedure; Up to 1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults aged 18 to 85 years undergoing elective outpatient screening colonoscopy for colon cancer screening

Exclusion Criteria:

Patients undergoing colonoscopy for any other indication besides colon cancer screening
Patients with prior colonic resections
Patients with chronic narcotic or benzodiazepine use
Poor bowel preparation (i.e. Boston bowel preparation score < 8)
Patients with obstructing colonic lesions detected on colonoscopy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 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
M. Brian Fennerty, MD	Oregon Health and Science University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oregon Health & Science University		Portland	Oregon	97239	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23021168	Derived	Lee BY, Katon R, Herzig D, Fennerty MB. Warm water infusion during sedated colonoscopy does not decrease amount of sedation medication used. Gastrointest Endosc. 2012 Dec;76(6):1182-7. doi: 10.1016/j.gie.2012.08.002. Epub 2012 Sep 26.