Prone Versus Left-sided Colonoscopy in Obese Patients | NCT01616602

Studies
Prone Versus Left-sided Colonoscopy in Obese Patients

NCT01616602

Sponsor

Dallas VA Medical Center

Status

Completed

Last Update Posted

Jun 12, 2012Estimated

Enrollment

100

Phase

Not Applicable

Conditions

Obese

Interventions

Prone Position
Standard Position

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 2011

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

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 8, 2012

First Submission Date that Met QC Criteria

Jun 11, 2012

First Posted Date

Jun 12, 2012Estimated

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

Jun 11, 2012

Last Update Posted Date

Jun 12, 2012Estimated

Description Module

Brief Summary

For obese patients, a randomized trial aimed at determining whether colonoscopy performance and patient comfort is improved if a patient is in the prone position (lay on their abdomen) versus the traditional left-sided position.

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

100

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Left-sided Position	Placebo Comparator		Other: Standard Position
Prone Position	Experimental		Other: Prone Position

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prone Position	Other	Patients were asked to lay on their abdomen for their elective colonoscopy.	Prone Position

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI >30kg/m2
Elective Colonoscopy

Exclusion Criteria:

Patients with prior colonic resection, strictures, or known colonic or intra-abdominal malignancy.
Patients who are scheduled to have monitored or general anesthesia for their procedure.
Emergency colonoscopy
Inadequate preparation of the colon as assessed during colonoscopy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Dallas VA Medical Center		Dallas	Texas	75216	United States

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016684	Prone Position

Ancestor Terms

ID	Term
D011187	Posture
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided