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

• Sponsor: Specialists in Gastroenterology, LLC (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01815671
• Collaborator: (none)
• Enrollment: 173
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 42.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diverticulosis	Procedure: colonoscopy in the lateral horizontal position	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 173 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Official Title: The Effect of Body Positioning for Colonoscopy in Women: Randomized, Study of Left Lateral Tilt Down Versus Left Lateral Horizontal Positioning
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Experience Adverse Events Which Are Related or Possibly Related to the Colonoscopy Procedure [24 hours]

   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.

Secondary Outcome Measures

1. Time to Full Colonoscope Insertion [30 minutes]

2. Pain Related or Possibly Related to Colonoscopy Procedure [24 hours]

   Visual Analogue Scale measured 0-4 with zero being no pain and 4 being most severe pain.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Advanced Endoscopy Center	St. Louis	Missouri	United States	63141

Sponsors and Collaborators

• Specialists in Gastroenterology, LLC

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Specialists in Gastroenterology, LLC
• ClinicalTrials.gov Identifier: NCT01815671
• Other Study ID Numbers: BP-1; Leonard Weinstock, MD
• First Posted: Mar 21, 2013
• Last Update Posted: Feb 5, 2014
• Last Verified: Feb 1, 2014

• Keywords provided by Specialists in Gastroenterology, LLC: colonoscopy; technique; tilt; insertion; safety; efficacy
• Additional relevant MeSH terms: Diverticulum; Diverticular Diseases

Study Results

Participant Flow

Recruitment Details	Consecutive women presenting to a private endoscopy center for colonoscopy (with or without a preceding upper endoscopy) were offered participation. A computer generated randomization code was used to assign subjects to either TD or LL group. Subjects were blinded to which group they were assigned.
Pre-assignment Detail	morbid obesity, 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

Arm/Group Title	Lateral Horizontal	Lateral Tilt Down
Arm/Group Description	Subjects randomized to receive colonoscopy in the lateral horizontal position	Subjects randomized to receive colonoscopy in the lateral tilt down position
Period Title: Overall Study
STARTED	88	85
COMPLETED	88	85
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Lateral Horizontal	Lateral Tilt Down	Total
Arm/Group Description	Subjects randomized to receive colonoscopy in the lateral horizontal position	Subjects randomized to receive colonoscopy in the lateral tilt down position	Total of all reporting groups
Overall Participants	88	85	173
Age (Count of Participants)
<=18 years	3 3.4%	4 4.7%	7 4%
Between 18 and 65 years	40 45.5%	50 58.8%	90 52%
>=65 years	45 51.1%	31 36.5%	76 43.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55 (12)	56 (11)	55 (11)
Sex: Female, Male (Count of Participants)
Female	88 100%	85 100%	173 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	88 100%	85 100%	173 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Experience Adverse Events Which Are Related or Possibly Related to the Colonoscopy Procedure
Description	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.
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lateral Horizontal	Lateral Tilt Down
Arm/Group Description	Subjects randomized to receive colonoscopy in the lateral horizontal position	Subjects randomized to receive colonoscopy in the lateral tilt down position
Measure Participants	88	85
Number [participants]	2 2.3%	9 10.6%

2. Secondary Outcome

Title	Time to Full Colonoscope Insertion
Time Frame	30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lateral Horizontal	Lateral Tilt Down
Arm/Group Description	Subjects randomized to receive colonoscopy in the lateral horizontal position	Subjects randomized to receive colonoscopy in the lateral tilt down position
Measure Participants	88	85
Mean (Standard Deviation) [minutes]	5.5 (1.2)	5.2 (1.1)

3. Secondary Outcome

Title	Pain Related or Possibly Related to Colonoscopy Procedure
Description	Visual Analogue Scale measured 0-4 with zero being no pain and 4 being most severe pain.
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lateral Horizontal	Lateral Tilt Down
Arm/Group Description	Subjects randomized to receive colonoscopy in the lateral horizontal position	Subjects randomized to receive colonoscopy in the lateral tilt down position
Measure Participants	88	85
Mean (Standard Deviation) [units on a scale]	0.36 (0.03)	0.28 (0.02)

Adverse Events

Arm/Group Title	Lateral Horizontal		Lateral Tilt Down
Arm/Group Description	Subjects randomized to receive colonoscopy in the lateral horizontal position		Subjects randomized to receive colonoscopy in the lateral tilt down position
All Cause Mortality
	Lateral Horizontal		Lateral Tilt Down
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Lateral Horizontal		Lateral Tilt Down
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/88 (0%)		0/85 (0%)
Other (Not Including Serious) Adverse Events
	Lateral Horizontal		Lateral Tilt Down
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/88 (2.3%)		9/85 (10.6%)
Cardiac disorders
bradycardia	2/88 (2.3%)	2	0/85 (0%)	0
Respiratory, thoracic and mediastinal disorders
oxygen desaturation	2/88 (2.3%)	2	9/85 (10.6%)	9

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.