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The aim of the study is to study the caecal intubation rate of a prototype ultra-thin colonoscope compared to a standard colonoscope and to study usefulness of this new colonoscope as a rescue instrument for failed initial colonoscopy with a standard colonoscope and to study the patient satisfaction scores using a validated endoscopy GHAA-9 for a new prototype colonoscope as compared to a standard colonoscope.
Colonoscopy is a common endoscopic procedure, widely used for the investigation of lower gastrointestinal tract diseases manifesting as altered bowel habit, per rectal bleeding and abdominal pain. It is used to diagnose colonic polyps, colorectal cancer and inflammatory bowel disease to name a few examples.
Colorectal cancer screening has been shown to decrease colorectal cancer. Despite this the uptake by the general population is suboptimal.
A new prototype colonoscope from Olympus with an additional distal bending section was designed. The investigators hypothesize that its performance characteristics will be similar to a standard colonoscope with patient tolerability.
This randomised control trial aims to invite patients attending their first outpatient colonoscopy and who are able to provide informed consent.(so they have had no prior experience) to assess the completion rate, patient and endoscopist satisfaction.
Patients with prior colorectal surgery or previous colonoscopy were excluded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Colonoscopy | Active Comparator | Colonoscopy with standard instrument |
|
| Ultra-thin colonoscopy | Experimental | New prototype scope |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Colonoscopy | Procedure | Standard colonoscopy will be used during colonoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful Caecal intubation | Success of Caecal intubation for the ultra-thin colonoscope vs standard colonoscope | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Caecal intubation time | Caecal intubation time Ultra-thin colonsocope vs standard colonoscope | 12 weeks |
| Patient Satisfaction and Pain score | Patient tolerability Ultra-thin vs standard colonoscope |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Y Lau | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endoscopy Center, Prince of Wales Hospital | Hong Kong | Hong Kong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21963069 | Derived | Luo DJ, Hui AJ, Yan KK, Ng SC, Wong VW, Chan FK, Cheong JP, Lam PP, Tse YK, Lau JY. A randomized comparison of ultrathin and standard colonoscope in cecal intubation rate and patient tolerance. Gastrointest Endosc. 2012 Mar;75(3):484-90. doi: 10.1016/j.gie.2011.07.032. Epub 2011 Oct 1. |
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| Ultra-thin colonoscopy | Procedure | Ultra-thin colonoscope will be used during colonoscopy |
|
| 12 weeks |
| Endoscopist satisfaction | Ease of use prototype scope vs standard colonoscope | 12 weeks |