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| ID | Type | Description | Link |
|---|---|---|---|
| Leonard Weinstock, MD | Other Identifier | Specialists in Gastroenterology |
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Increased number of oxygen desaturation in tilt down position
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lateral horizontal body position | Other | Subjects randomized to receive colonoscopy in the lateral horizontal position, This is the standard position. The other position - tilt down is the intervention |
|
| Lateral tilt down body position | Other | Subjects randomized to receive colonoscopy in the lateral tilt down position |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| colonoscopy in the lateral horizontal position | Procedure | colonoscopy in the lateral horizontal position with tilt down |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leonard B Weinstock, MD | Specialists in Gastroenterology, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Endoscopy Center | St Louis | Missouri | 63141 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19481671 | Background | 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. |
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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
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lateral Horizontal | Subjects randomized to receive colonoscopy in the lateral horizontal position |
| FG001 | Lateral Tilt Down | Subjects randomized to receive colonoscopy in the lateral tilt down position |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lateral Horizontal | Subjects randomized to receive colonoscopy in the lateral horizontal position |
| BG001 | Lateral Tilt Down | Subjects randomized to receive colonoscopy in the lateral tilt down position |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | 24 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lateral Horizontal | Subjects randomized to receive colonoscopy in the lateral horizontal position |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bradycardia | Cardiac disorders | Systematic Assessment | pulse less than 50 requiring medication |
Early termination owing to increased incidence of oxygen desaturation in the tilt down group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leonard Weinstock, MD | Specialists in Gastroenterology, LLC | 314-997-0554 | 102 | lw@gidoctor.net |
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| ID | Term |
|---|---|
| D004240 | Diverticulum |
| ID | Term |
|---|---|
| D000076385 | Diverticular Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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| 24 hours |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Time to Full Colonoscope Insertion | Posted | Mean | Standard Deviation | minutes | 30 minutes |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 24 hours |
|
|
|
| 0 |
| 88 |
| 2 |
| 88 |
| EG001 | Lateral Tilt Down | Subjects randomized to receive colonoscopy in the lateral tilt down position | 0 | 85 | 9 | 85 |
|
| oxygen desaturation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | oxygen saturation less than 90 mm Hg for any length of time |
|
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| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |