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临床试验/NCT05422820
NCT05422820已完成不适用

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

Institute of Gastroenterology and Advance Endoscopy1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
5,000
试验地点
1
主要终点
Argentina Bowel Complexity and Colonoscopy technical Difficulty score (ABCD)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Argentina Bowel Complexity and Colonoscopy technical Difficulty score (ABCD)

时间窗: Six months

Per each colonoscopy, there were documented: 1. The number of cases in which caecal intubation (CI) was or was not achieved. 2. Number of endoscopists who participated until caecal intubation, with the respective learning curve experience (expert/senior vs. non-expert/junior); 3. Requirement of restart colonoscopy (regardless of the responsible endoscopist); 4. Requirement of at least one postural change (from lateral to supine or vice versa); 5. 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.

次要结局

  • Post-colonoscopy pain(Six months)
  • Required anaesthesia dose(During procedure: no more than 30 minutes.)
  • Caecal intubation and colonoscope withdrawal time(During procedure: no more than 30 minutes.)

研究者

发起方
Institute of Gastroenterology and Advance Endoscopy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Manuel Valero

Principal investigator - Physician - GI Attending

Institute of Gastroenterology and Advance Endoscopy

研究点 (1)

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