The Argentina Brief Colonoscopy Difficulty Score (ABCD) (ABCD)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer; Polyp of Colon; Diagnoses Disease; Adenoma Colon
• Intervention / Treatment: Diagnostic test: Diagnostic high-definition white-light (HDWL) colonoscopy

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 9603

Contacts and Locations

• Study Contact: Name: Miguel Puga-Tejada, MD MSc; Phone Number: +5491165003311; Email: miguel.puga01@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with an indication of colonoscopy with caecal intubation, regardless of clinical purpose.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institute of Gastroenterology and Advance Endoscopy
• Collaborators: Austral University, Argentina; Hospital Nacional Profesor Alejandro Posadas

Publications and helpful links

General Publications

• Jia H, Wang L, Luo H, Yao S, Wang X, Zhang L, Huang R, Liu Z, Kang X, Pan Y, Guo X. Difficult colonoscopy score identifies the difficult patients undergoing unsedated colonoscopy. BMC Gastroenterol. 2015 Apr 9;15:46. doi: 10.1186/s12876-015-0273-7.
• Fritz CDL, Smith ZL, Elsner J, Hollander T, Early D, Kushnir V. Prolonged Cecal Insertion Time Is Not Associated with Decreased Adenoma Detection When a Longer Withdrawal Time Is Achieved. Dig Dis Sci. 2018 Nov;63(11):3120-3125. doi: 10.1007/s10620-018-5100-x. Epub 2018 May 3.
• Allen JI. Quality measures for colonoscopy: where should we be in 2015? Curr Gastroenterol Rep. 2015 Mar;17(3):10. doi: 10.1007/s11894-015-0432-6.
• ASGE Technology Committee, Trindade AJ, Lichtenstein DR, Aslanian HR, Bhutani MS, Goodman A, Melson J, Navaneethan U, Pannala R, Parsi MA, Sethi A, Sullivan S, Thosani N, Trikudanathan G, Watson RR, Maple JT. Devices and methods to improve colonoscopy completion (with videos). Gastrointest Endosc. 2018 Mar;87(3):625-634. doi: 10.1016/j.gie.2017.12.011. No abstract available.
• Clancy C, Burke JP, Chang KH, Coffey JC. The effect of hysterectomy on colonoscopy completion: a systematic review and meta-analysis. Dis Colon Rectum. 2014 Nov;57(11):1317-23. doi: 10.1097/DCR.0000000000000223.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: June 12, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 1, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Colonoscopy; Quality of health care; Endoscopist; Technical difficulty
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Adenoma; Colonic Polyps
• Other Study ID Numbers: IGEA01-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No