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| Name | Class |
|---|---|
| Sykehuset Telemark | OTHER_GOV |
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A prototype colonoscope with an extra passively bending distal section has been developed by Olympus Japan (ref. publications). The present study (2006-2007) is testing refinements of this function.
Results from the first prototype evaluation has been published.Modifications are presently evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prototype colonoscope | Active Comparator | Colonoscopy using prototype colonoscope with passive bending function |
|
| Standard colonoscope | Placebo Comparator | Colonoscopy using standard colonoscope with no passive bending function |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Passive bending function | Device | Colonoscope with a passive bending function |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Assessment of Pain Experienced During Colonoscopy | The proportion of patients reporting "no pain" when examined with prototype or standard colonoscope, respectively. Pain experienced was assessed by the patient in a questionnaire to be filled in at home on the day after the examination and mailed in a pre-paid envelope to a national quality register (Gastronet). | Pain experienced during colonoscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geir Hoff, MD, PhD | Head of Research, Telemark Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology section, Dept. of Medicine, Telemark Hospital | Skien | 3710 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20923378 | Background | Hoff G, Moritz V, Bretthauer M, Ludolph T, Huppertz-Hauss G, Paulsen J, Seip B, Sauar J, Kjellevold O, Chengarov L. Colonoscope with a sub-distal hyper-flaccid segment for improved insertion at colonoscopy: a randomized study. Scand J Gastroenterol. 2011 Jan;46(1):104-8. doi: 10.3109/00365521.2010.521891. Epub 2010 Oct 6. | |
| 16281143 |
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Exclusion criteria were pregnancy, age younger than 18 years, previous resection for colorectal disease and inability to comprehend the information given.
120 patients, routinely referred for outpatients colonosciopy, were randomized 1:1 to examination with protototype or standard colonoscope.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prototype Colonoscope | Colonoscopy using prototype colonoscope |
| FG001 | Standard Colonoscope | Colonoscopy using standard colonoscope without a passive bending function |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients referred to routine outpatients' colonoscopy
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 Prototype Colonoscope | Colonoscopy using prototype colonoscope |
| BG001 | 2 Standard Colonoscope | Colonoscopy using standard colonoscope without a passive bending function |
| 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 | Patient Assessment of Pain Experienced During Colonoscopy | The proportion of patients reporting "no pain" when examined with prototype or standard colonoscope, respectively. Pain experienced was assessed by the patient in a questionnaire to be filled in at home on the day after the examination and mailed in a pre-paid envelope to a national quality register (Gastronet). | Power estimates based on assumption of 20% difference in pain-free examination comparing groups | Posted | Number | participants | Pain experienced during colonoscopy |
|
Adverse event registration was based on events observed during the patient's stay in the endoscopy unit and information from a patient report form to be filled in by the patient on the day after the examination.
Patients were provided with a patient report form to be returned to the national quality assurance register Gastronet in a prepaid return envelope on the day after the colonoscopy.
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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 | Prototype Colonoscope | The prototype colonoscope is in effect a standard Olympus endoscope with one exception: about 10cm proximal to the distal, actively bending tip, there is a more falccid section which bends passively in all directions against external pressure. It is hypothesized that this will ease passage through sharp bends (flexures). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Geir Hoff | NorwegianDohsa | +4791866762 | hofg@online.no |
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| ID | Term |
|---|---|
| D003092 | Colitis |
| D000236 | Adenoma |
| D002277 | Carcinoma |
| D003109 | Colonic Diseases, Functional |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D003108 | Colonic Diseases |
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| No passive bending function | Device | Examination using standard colonoscope without passive bending function |
|
|
| Hoff G, Bretthauer M, Huppertz-Hauss G, Sauar J, Paulsen J, Dahler S, Kjellevold O. Evaluation of a novel colonoscope designed for easier passage through flexures: a randomized study. Endoscopy. 2005 Nov;37(11):1123-6. doi: 10.1055/s-2005-870444. |
| 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 |
|
Colonoscopy using standard colonoscope without a passive bending function
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Standard Colonoscope | Colonoscope without a distal actively bending section | 0 | 60 | 0 | 60 | 0 | 60 |
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| D007410 |
| Intestinal Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |