The Argentina Brief Colonoscopy Difficulty Score (ABCD)

NCT05422820 | Completed DMC

• 1 other identifier: IGEA01-2022
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer; Diagnoses Disease; Polyp of Colon; Adenoma Colon

Keywords

Colonoscopy; Quality of health care; Endoscopist; Technical difficulty

Outcome Measures

Primary Outcomes (1)

• Argentina Bowel Complexity and Colonoscopy technical Difficulty score (ABCD)

  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.

  Six months

Secondary Outcomes (3)

• Caecal intubation and colonoscope withdrawal time

  During procedure: no more than 30 minutes.

• Required anaesthesia dose

  During procedure: no more than 30 minutes.

• Post-colonoscopy pain

  Six months

Interventions

Diagnostic high-definition white-light (HDWL) colonoscopy DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Gastroenterology and Advance Endoscopy: lead
• Austral University, Argentina: collaborator
• Hospital Nacional Profesor Alejandro Posadas: collaborator

Study Sites (1)

Manuel Valero

Bahía Blanca, Buenos Aires, B8000, Argentina

Location

Related Publications (5)

• 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.

  PMID: 25886845 BACKGROUND

• 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.

  PMID: 29721773 BACKGROUND

• 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.

  PMID: 25740247 BACKGROUND

• 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.

  PMID: 29454445 BACKGROUND

• 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.

  PMID: 25285700 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Polyps

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator - Physician - GI Attending

Study Record Dates

• First Submitted: June 12, 2022
• First Posted: June 21, 2022
• Study Start: July 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: October 31, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)