NCT01616602

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2012

Completed
Last Updated

June 12, 2012

Status Verified

December 1, 2011

First QC Date

June 8, 2012

Last Update Submit

June 11, 2012

Conditions

Obese

Keywords

patientspresentingelectivecolonoscopy.

Study Arms (2)

Left-sided Position

PLACEBO COMPARATOR
Other: Standard Position

Prone Position

EXPERIMENTAL
Other: Prone Position

Interventions

Prone PositionOTHER

Patients were asked to lay on their abdomen for their elective colonoscopy.

Prone Position
Standard PositionOTHER

The traditional left-lateral decubitus position

Left-sided Position

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \>30kg/m2
  • Elective Colonoscopy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Prone Position

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

June 8, 2012

First Posted

June 12, 2012

Last Updated

June 12, 2012

Record last verified: 2011-12

Locations

US(1)