Evaluate the Safety and Diagnostic Advantages of Tilt Down Verses Standard Horizontal Colonoscopy Positioning (CTDTTIE)

The Effect of Body Positioning for Colonoscopy in Women: Randomized, Study of Left Lateral Tilt Down Versus Left Lateral Horizontal Positioning

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.

Study Overview

• Status: Terminated
• Conditions: Diverticulosis
• Intervention / Treatment: Procedure: colonoscopy in the lateral horizontal position

Detailed Description

This was a prospective, randomized study. Subjects who provide informed consent and present to the offices of Specialists in Gastroenterology for colonoscopy will be randomized in a 1:1 distribution to either left lateral tilt down versus left lateral horizontal positioning to initiate colonoscopy.

Demographic data as well as routine information regarding the colonoscopy was filled out during or at the end of each procedure. In addition, the following parameters were assessed, and compared between groups:

1. Occurrence of complications related or possibly related to the colonoscopy procedure
2. Scope insertion time
3. Pain during and after the procedure

The subjects' participation was limited to the duration of the colonoscopy, which is typically less than 60 min and a follow up by telephone 24 hours later to assess the occurrence of complications.

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States, 63141
      • Advanced Endoscopy Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• active pulmonary infection
• liquid intake <2 hours
• solid food intake <8 hours prior to the procedure
• intra-procedure findings of a stricture resulting in an incomplete colonoscopy or Boston bowel preparation scores of <6

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lateral horizontal body position; 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; colonoscopy in the lateral horizontal position with tilt down
Other: Lateral tilt down body position; Subjects randomized to receive colonoscopy in the lateral tilt down position	Procedure: colonoscopy in the lateral horizontal position; colonoscopy in the lateral horizontal position with tilt down

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Full Colonoscope Insertion		30 minutes
Pain Related or Possibly Related to Colonoscopy Procedure	Visual Analogue Scale measured 0-4 with zero being no pain and 4 being most severe pain.	24 hours

Collaborators and Investigators

• Sponsor: Specialists in Gastroenterology, LLC
• Investigators: Principal Investigator: Leonard B Weinstock, MD, Specialists in Gastroenterology, LLC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: March 18, 2013
• First Submitted That Met QC Criteria: March 20, 2013
• First Posted (Estimate): March 21, 2013

Study Record Updates

• Last Update Posted (Estimate): February 5, 2014
• Last Update Submitted That Met QC Criteria: February 4, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: safety; colonoscopy; efficacy; technique; tilt; insertion
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Pathological Conditions, Anatomical; Diverticulum; Diverticular Diseases
• Other Study ID Numbers: BP-1; Leonard Weinstock, MD (Other Identifier: Specialists in Gastroenterology)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No