Trial Outcomes & Findings for Evaluate the Safety and Diagnostic Advantages of Tilt Down Verses Standard Horizontal Colonoscopy Positioning (NCT NCT01815671)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

173 participants

Primary outcome timeframe

24 hours

Results posted on

2014-02-05

Participant Flow

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.

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

Participant milestones

Participant milestones
Measure	Lateral Horizontal Subjects randomized to receive colonoscopy in the lateral horizontal position	Lateral Tilt Down Subjects randomized to receive colonoscopy in the lateral tilt down position
Overall Study STARTED	88	85
Overall Study COMPLETED	88	85
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lateral Horizontal n=88 Participants Subjects randomized to receive colonoscopy in the lateral horizontal position	Lateral Tilt Down n=85 Participants Subjects randomized to receive colonoscopy in the lateral tilt down position	Total n=173 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants	50 Participants n=7 Participants	90 Participants n=5 Participants
Age, Categorical >=65 years	45 Participants n=5 Participants	31 Participants n=7 Participants	76 Participants n=5 Participants
Age, Continuous	55 years STANDARD_DEVIATION 12 • n=5 Participants	56 years STANDARD_DEVIATION 11 • n=7 Participants	55 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	88 Participants n=5 Participants	85 Participants n=7 Participants	173 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	88 participants n=5 Participants	85 participants n=7 Participants	173 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Lateral Horizontal n=88 Participants Subjects randomized to receive colonoscopy in the lateral horizontal position	Lateral Tilt Down n=85 Participants Subjects randomized to receive colonoscopy in the lateral tilt down position
Number of Participants Who Experience Adverse Events Which Are Related or Possibly Related to the Colonoscopy Procedure	2 participants	9 participants

SECONDARY outcome

Timeframe: 30 minutes

Outcome measures

Outcome measures
Measure	Lateral Horizontal n=88 Participants Subjects randomized to receive colonoscopy in the lateral horizontal position	Lateral Tilt Down n=85 Participants Subjects randomized to receive colonoscopy in the lateral tilt down position
Time to Full Colonoscope Insertion	5.5 minutes Standard Deviation 1.2	5.2 minutes Standard Deviation 1.1

SECONDARY outcome

Timeframe: 24 hours

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

Outcome measures

Outcome measures
Measure	Lateral Horizontal n=88 Participants Subjects randomized to receive colonoscopy in the lateral horizontal position	Lateral Tilt Down n=85 Participants Subjects randomized to receive colonoscopy in the lateral tilt down position
Pain Related or Possibly Related to Colonoscopy Procedure	0.36 units on a scale Standard Deviation 0.03	0.28 units on a scale Standard Deviation 0.02

Adverse Events

Lateral Horizontal

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Lateral Tilt Down

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lateral Horizontal n=88 participants at risk Subjects randomized to receive colonoscopy in the lateral horizontal position	Lateral Tilt Down n=85 participants at risk Subjects randomized to receive colonoscopy in the lateral tilt down position
Cardiac disorders bradycardia	2.3% 2/88 • Number of events 2	0.00% 0/85
Respiratory, thoracic and mediastinal disorders oxygen desaturation	2.3% 2/88 • Number of events 2	10.6% 9/85 • Number of events 9

Additional Information

Leonard Weinstock, MD

Specialists in Gastroenterology, LLC

Phone: 314-997-0554

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place