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

Diverticulosis Clinical Trial

— CTDTTIE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01815671
• Other study ID #: BP-1
• Secondary ID: Leonard Weinstoc
• Status: Terminated
• Phase: N/A
• First received: March 18, 2013
• Last updated: February 4, 2014
• Start date: May 2012
• Est. completion date: September 2012

Study information

• Verified date: February 2014
• Source: Specialists in Gastroenterology, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 173
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Diverticulosis
• Diverticulum

Intervention

Procedure:
• colonoscopy in the lateral horizontal position
colonoscopy in the lateral horizontal position with tilt down

Locations

Country	Name	City	State
United States	Advanced Endoscopy Center	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Specialists in Gastroenterology, LLC

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Time to Full Colonoscope Insertion		30 minutes	No
Secondary	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	No