A Comparison of an Ultra-thin and Standard Colonoscope in Achieving Caecal Intubation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Study to Assess the Success Rate of Ultra-thin Colonoscopy Versus Conventional Colonoscopy for the First or Rescue Colonoscopy for Unsuccessful Procedures (UTC Study).

Conditions
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First Colonoscopy Examination

Intervention / Treatment
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* Procedure: Standard Colonoscopy
* Procedure: Ultra-thin colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First outpatient colonoscopy Able to provide informed consent Exclusion Criteria: Unable to provide consent Prior colon surgery (except appendectomy)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Colonoscopy<br>Colonoscopy with standard instrument | Procedure: Standard Colonoscopy<br>* Standard colonoscopy will be used during colonoscopy<br>|
| Experimental: Ultra-thin colonoscopy<br>New prototype scope | Procedure: Ultra-thin colonoscopy<br>* Ultra-thin colonoscope will be used during colonoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Caecal intubation | Success of Caecal intubation for the ultra-thin colonoscope vs standard colonoscope | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 12 weeks | 
| Endoscopist satisfaction | Ease of use prototype scope vs standard colonoscope | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultra-thin colonoscope