Diverticulosis
Conditions
Keywords
colonoscopy, technique, tilt, insertion, safety, efficacy
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.
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.
Interventions
PROCEDUREcolonoscopy in the lateral horizontal position
colonoscopy in the lateral horizontal position with tilt down
Sponsors
Specialists in Gastroenterology, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Time to Full Colonoscope Insertion | 30 minutes | — |
| 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. |
Countries
United States
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 details
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
Participants by arm
| Arm | Count |
|---|---|
| Lateral Horizontal Subjects randomized to receive colonoscopy in the lateral horizontal position | 88 |
| Lateral Tilt Down Subjects randomized to receive colonoscopy in the lateral tilt down position | 85 |
| Total | 173 |
Baseline characteristics
| Characteristic | Lateral Tilt Down | Lateral Horizontal | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 4 Participants | 3 Participants | 7 Participants |
| Age, Categorical >=65 years | 31 Participants | 45 Participants | 76 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 40 Participants | 90 Participants |
| Age, Continuous | 56 years STANDARD_DEVIATION 11 | 55 years STANDARD_DEVIATION 12 | 55 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 85 participants | 88 participants | 173 participants |
| Sex: Female, Male Female | 85 Participants | 88 Participants | 173 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 88 | 9 / 85 |
| serious Total, serious adverse events | 0 / 88 | 0 / 85 |
Outcome results
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.
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lateral Horizontal | Number of Participants Who Experience Adverse Events Which Are Related or Possibly Related to the Colonoscopy Procedure | 2 participants |
| Lateral Tilt Down | Number of Participants Who Experience Adverse Events Which Are Related or Possibly Related to the Colonoscopy Procedure | 9 participants |
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.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lateral Horizontal | Pain Related or Possibly Related to Colonoscopy Procedure | 0.36 units on a scale | Standard Deviation 0.03 |
| Lateral Tilt Down | Pain Related or Possibly Related to Colonoscopy Procedure | 0.28 units on a scale | Standard Deviation 0.02 |
Secondary
Time to Full Colonoscope Insertion
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lateral Horizontal | Time to Full Colonoscope Insertion | 5.5 minutes | Standard Deviation 1.2 |
| Lateral Tilt Down | Time to Full Colonoscope Insertion | 5.2 minutes | Standard Deviation 1.1 |