The Argentina Brief Colonoscopy Difficulty Score (ABCD)

Study Overview
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Brief Summary
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Colonoscopy completion by caecal intubation seldom represents a significant effort for the endoscopist. In this situation, additional techniques are necessary to achieve this goal: patients' manual abdominal compression, postural changes, and endoscopist relay. To date, no tool allows colonoscopy technical difficulty grading. This study pursues to describe the frequency of additional techniques for caecal intubation in a large sample of Argentinians in different centres who undergo colonoscopy for attending purposes, to develop a novel score for assessing colonoscopy technical difficulty.

Detailed Description
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Colonoscopy is the most performed digestive endoscopy procedure worldwide. It is indicated for colorectal cancer screening, pre-existence surveillance, diagnostic approach in symptomatic patients, and therapeutic purposes. Bowel preparation is the most crucial quality criterion that guarantees appropriate colonic mucosa assessment. Other colonoscopy quality criteria included a colonoscope withdrawal time above 6 to 10 minutes and colonoscopy completion by caecal intubation. Besides bowel preparation, some situations limit caecal intubation: stenosis, diverticulitis, or haemodynamic instability. In the absence of one of those situations or similar, caecal intubation must be the goal to be achieved by every endoscopist. However, it sometimes represents a significant effort for the endoscopist. It can require additional techniques such as manual abdominal compression, postural changes, colonoscopy restart, and another endoscopist's new attempt. Also, this increases caecal intubation time by over 10 minutes, more anaesthesia and post-colonoscopy abdominal pain, with a higher risk of unnoticed lesions. To the best of our knowledge, there is no standard definition for colonoscopy technical difficulty in terms of caecal intubation or any tool that grades it based on previously mentioned additional techniques. For the moment, developed tools such as the Difficult Colonoscopy Score (DCS) to consider patients' pre-colonoscopy factors such as age, body mass index (BMI), sleep quality, and endoscopist experience. Other tools are based on a qualitative appreciation of the technical difficulty. A tool that documents those endpoints constitutes an additional objective quality criterion for colonic mucosa assessment, with critical change management during intra-colonoscopy and post-colonoscopy. Noticed a technically difficult colonoscopy deserves a more prolonged withdrawal time, more photo documentation, a more cautious discharge, more detailed patient instructions, and a personalised follow-up directed to adverse events warnings. A patient with a previous technically difficult colonoscopy will be planned for an earlier next colonoscopy, with a risk assessment independently on the age, pre-colonoscopy consulting with detailing of more potential adverse events, planned in a particular time and with a different anaesthesia planning, and even performed by a more experienced endoscopist or in a referral centre. This study pursues to describe the frequency of additional techniques for caecal intubation in a large sample of Argentinians in different centres who undergo colonoscopy for attending purposes, to develop a novel score for assessing colonoscopy technical difficulty.

Official Title
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The Argentina Brief Colonoscopy Difficulty Score (ABCD): A Novel Tool to Estimate the Technical Difficulty of Colonoscopy With Caecal Intubation

Conditions
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Colorectal Cancer, Diagnoses Disease, Polyp of Colon, Adenoma Colon

Intervention / Treatment
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* Diagnostic Test: Diagnostic high-definition white-light (HDWL) colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with colonoscopy indication due to colorectal cancer screening, pre-existence surveillance, or diagnostic approach in symptomatic patients. Patients with colonoscopy indication due to therapeutic purposes, but with the intention of caecal intubation. Exclusion Criteria: Patients with a previous colonoscopy performed by the attending centre in the last three months. Patients with a Boston Bowel Preparation Score (BBPS) ≤1 in at least one colon segment (ascending, transverse, descending). Patients with any situations which does not allow caecal intubation: colorectal stenosis, diverticulitis, the indication of proctosigmoidoscopy for assessing ulcerative colitis, or intraprocedural haemodynamic instability, among others. Patients with any contraindication for an invasive procedure: uncontrolled coagulopathy, kidney/liver failure or any comorbidity with an important impact on cardiac risk assessment or physical status: New York Heart Association (NYHA) risk III/IV, or American Society Association (ASA) risk III-V, respectively.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Diagnostic high-definition white-light (HDWL) colonoscopy|All participants will undergo to colonoscopy examination performed by competent/junior or expert/senior endoscopists (>150-400 or >400 previous colonoscopies, respectively). Bowel preparation was performed using different solutions, according to the clinical discretion of the attending, who indicated colonoscopy. After deep sedation by intravenous propofol with or without fentanyl or midazolam administration, a water-assisted colonoscopy was performed using a high-definition (HD) scope with white light (WL). Colonoscope trademark differs among participant centres.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Argentina Bowel Complexity and Colonoscopy technical Difficulty score (ABCD) | Per each colonoscopy, there were documented: The number of cases in which caecal intubation (CI) was or was not achieved. Number of endoscopists who participated until caecal intubation, with the respective learning curve experience (expert/senior vs. non-expert/junior); Requirement of restart colonoscopy (regardless of the responsible endoscopist); Requirement of at least one postural change (from lateral to supine or vice versa); Requirement of manual abdominal pressure. ABCD score ranges from 0 to IV: 0: no difficulty. I: low difficulty. CI was issued after an effective abdominal compression. II: mild difficulty. CI was issued after a partial effective abdominal compression. III: high difficulty. CI was issued after body rotation or change of endoscopist. IV: very high difficulty. Declined cecal intubation after several attempts using additional techniques. | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caecal intubation and colonoscope withdrawal time | The caecal intubation time (CIT) is the time (mm:ss) from colonoscope insertion to the anal margin until caecal intubation (or its desertion after several attempts). Biopsy or therapeutic time will not be considered for this research. The colonoscope withdrawal time (CWT) is the time (mm:ss) from caecal intubation (or its desertion after several attempts) until the returning to the anal margin after assessing the colonic mucosa thoroughly. Biopsy or therapeutic time will not be considered for this research. | During procedure: no more than 30 minutes. | 
| Required anaesthesia dose | Dose of propofol (mg) with or without fentanyl (mcg) or midazolam (mg) used during colonoscopy, following anaesthesia record. | During procedure: no more than 30 minutes. | 
| Post-colonoscopy pain | Level of pain described by the patient one-hour post-colonoscopy. A general practitioner blind to the ABCD findings will ask the patient about pain from 1 (one) to 10 (ten), showing the Wong-Baker face pain rating scale, a type of visual analogue scale (VAS). | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Quality of health care, Endoscopist, Technical difficulty