Position Changes During Colonoscope Insertion Increases P... | NCT01433939

Studies
Position Changes During Colonoscope Insertion Increases Patient Comfort

NCT01433939

Sponsor

Jennifer Telford

Status

Completed

Last Update Posted

May 2, 2018Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Colonoscopy Technique

Interventions

Not provided

Countries

Canada

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

Apr 2018

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

Sep 2011

Primary Completion Date

May 25, 2015Actual

Completion Date

May 25, 2015Actual

First Submitted Date

Sep 12, 2011

First Submission Date that Met QC Criteria

Sep 13, 2011

First Posted Date

Sep 14, 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

Apr 30, 2018

Last Update Posted Date

May 2, 2018Actual

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 investigators wish to study the effects of position changes during colonoscope insertion on patient comfort. The investigators hypothesize that early position changes would reduce colonoscope loop formation and patient discomfort.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intensity and frequency of abdominal pain	Abdominal pain during colonoscopy.	30min

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 19 years or older
outpatient colonoscopy

Exclusion Criteria:

inpatient
unable to provide informed consent
previous bowel resection, inflammatory bowel disease
musculoskeletal disorder or other mobility issues limiting effective patient position changes.
inadequate bowel preparation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients referred to gastroenterologists for colonoscopy.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jennifer Telford, MD	The University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Paul's Hospital		Vancouver	British Columbia	V6Z 1Y6	Canada