NCT01815671

Brief Summary

A tortuous sigmoid colon makes colonoscopy difficult. The purpose of this study was to systematically evaluate the diagnostic utility and incidence of adverse events in women using standard horizontal compared to lateral tilt down positioning for colonoscopy.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

May 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2013

Completed
11 months until next milestone

Results Posted

Study results publicly available

February 5, 2014

Completed
Last Updated

February 5, 2014

Status Verified

February 1, 2014

Enrollment Period

4 months

First QC Date

March 18, 2013

Results QC Date

June 2, 2013

Last Update Submit

February 4, 2014

Conditions

Diverticulosis

Keywords

colonoscopytechniquetiltinsertionsafetyefficacy

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Experience Adverse Events Which Are Related or Possibly Related to the Colonoscopy Procedure

    The number of participants who experience adverse events which are related or possibly related to the colonoscopy procedure will be tallied in each treatment arm.

    24 hours

Secondary Outcomes (2)

  • Time to Full Colonoscope Insertion

    30 minutes

  • Pain Related or Possibly Related to Colonoscopy Procedure

    24 hours

Study Arms (2)

Lateral horizontal body position

OTHER

Subjects randomized to receive colonoscopy in the lateral horizontal position, This is the standard position. The other position - tilt down is the intervention

Procedure: colonoscopy in the lateral horizontal position

Lateral tilt down body position

OTHER

Subjects randomized to receive colonoscopy in the lateral tilt down position

Procedure: colonoscopy in the lateral horizontal position

Interventions

colonoscopy in the lateral horizontal positionPROCEDURE

colonoscopy in the lateral horizontal position with tilt down

Lateral horizontal body positionLateral tilt down body position

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ability to understand and sign consent
  • women and men with a BMI (body mass index) \<35 kg/m2
  • age 18 - 90 years
  • no liquids by mouth for ≥2 hours
  • no solid food for ≥8 hours

You may not qualify if:

  • inability to provide informed consent
  • morbid obesity (BMI ≥35)
  • pregnancy
  • uncontrolled gastroesophageal reflux disease
  • gastroparesis
  • scleroderma
  • achalasia
  • Crohn's disease
  • ulcerative colitis
  • history of a colon resection
  • Parkinson's disease
  • brain tumor
  • multiple sclerosis
  • ischemic optic neuropathy
  • glaucoma
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advanced Endoscopy Center

St Louis, Missouri, 63141, United States

Location

Related Publications (1)

  • Weinstock LB. Body positions for colonoscopy: value of Trendelenburg. Gastrointest Endosc. 2009 Jun;69(7):1409-10. doi: 10.1016/j.gie.2008.09.039. No abstract available.

    PMID: 19481671BACKGROUND

MeSH Terms

Conditions

Diverticulum

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Diverticular DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Limitations and Caveats

Early termination owing to increased incidence of oxygen desaturation in the tilt down group.

Results Point of Contact

Title
Leonard Weinstock, MD
Organization
Specialists in Gastroenterology, LLC
lw@gidoctor.net
314-997-0554

Study Officials

  • Leonard B Weinstock, MD

    Specialists in Gastroenterology, LLC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2013

First Posted

March 21, 2013

Study Start

May 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

February 5, 2014

Results First Posted

February 5, 2014

Record last verified: 2014-02

Locations

US(1)