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This protocol adheres to the guidelines approved by the Ethics Committee of Dongzhimen Hospital, Beijing University of Chinese Medicine (Ethics No. 2023DZMEC-043-02). All participants provided written informed consent prior to the study enrolment.
Patient selection
The study was conducted between 30 July 2021 and 1 August 2022 and involved patients undergoing unsedated colonoscopy at Beijing University of Chinese Medicine. The following inclusion criteria were applied: patients were aged 18–80 years; written informed consent to participate was provided; and one or more of the following conditions were present: unexplained lower gastrointestinal bleeding, chronic diarrhoea, abdominal mass, lower/middle abdominal pain, suspected bowel tumour, suspected chronic bowel inflammation, or unexplained low-level bowel obstruction. Patients with the following conditions were excluded: inflammatory bowel disease, colorectal cancer, history of abdominal surgery or postoperative colon conditions, ileostomy, ischaemic bowel disease, intestinal obstruction, post-diverticulitis, insufficient bowel preparation, and severe underlying conditions (e.g. malignant hypertension, coronary heart disease with long-term anticoagulant use, poor cardiopulmonary function). Eligible patients were divided into completion and incompletion groups based on whether the colonoscopy reached the ileocecal junction or appendiceal fossa (documented in examination reports) using convenience sampling.
Pre-examination preparation
Patients were instructed to maintain a light diet for 3 days prior to the examination to reduce intestinal residue. First, 4 L of polyethylene glycol electrolyte powder solution was administered for bowel cleansing, with patients taking the laxative the night before the examination (with the total volume ingested over a period of 2-3 h). A 4–6 h interval was maintained between bowel preparation completion and colonoscopy to ensure optimal intestinal cleanliness. Patient compliance with the diet and laxative regimen was verified through verbal inquiry on the examination day.
Equipment and materials preparation
An electronic colonoscope (see Table of Materials for specifications) was prepared. The device was initialized with standard settings: standard white light imaging (WLI) mode was selected, and the air insufflation pump was set to a standard flow rate (level "Medium" or "High" depending on your device). A self-rating anxiety scale, Visual Analogue Scale (VAS) assessment form, Ottawa bowel preparation scale, and standardised data collection sheet. The availability of monitoring equipment (blood pressure monitor, pulse oximeter) and emergency supplies (oxygen, resuscitation equipment) in the examination room was checked, and all measurement tools (tape measure, stopwatch) were calibrated before use.
Examination procedure
The patient was placed in the left lateral position on the examination table, and their comfort was verified before initiating the procedure. The colonoscope was inserted through the anus under direct visualisation, advancing by following the intestinal physiological shape and adjusting direction to avoid wall injury. The time taken to reach the ileocecal valve from anus insertion was recorded using a stopwatch (starting at insertion, ending at visualisation of the ileocecal junction or appendiceal fossa). If the patient experienced severe discomfort (e.g. persistent abdominal pain, severe distension, palpitation, nausea) during the procedure, colonoscopy was immediately terminated, and the patient was transferred to the ward for observation and symptomatic treatment if necessary. Examinations were conducted by one of two board-certified gastroenterologists with distinct experience levels (see Endoscopist classification section).
Endoscopist classification
The endoscopists were classified according to the American Society for Gastrointestinal Endoscopy criteria and the Kudo classification system18. The experienced endoscopist (Physician 1) had ≥ 15 years of colonoscopy experience with > 7,500 total procedures (average 500/year), was Gongteng Grade IV (expert level), and had achieved caecal intubation times of < 10 minutes in > 90% of routine cases. The less-experienced endoscopist (Physician 2) had 8 years of experience with approximately 3,200 total procedures (average 400/year) and was Gongteng Grade III (proficient level). The endoscopist performing each examination was documented.
Data collection
Pre-examination demographic and clinical data collected: sex, age, body mass index (BMI), abdominal circumference (measured with a standard tape measure at the umbilical level), constipation history (diagnosed by the Rome IV criteria: ≥ 2 of 6 characteristic symptoms in the past 3 months) and anxiety level (assessed via the self-rating anxiety scale with 20 questions: total score < 50 = normal, 50–59 = mild anxiety [Grade 1], 60–69 = moderate anxiety [Grade 2], > 69 = severe anxiety [Grade 3])19,20.
Intra-procedural data collected: time to ileocecal junction and the reason for incomplete examination (if applicable: pain, poor bowel preparation, tumour stenosis).
Post-examination data collected: bowel preparation quality (evaluated by endoscopists immediately post-procedure using the Ottawa bowel preparation scale, categorised as excellent, good, moderate or poor) and pain level (assessed by nurses within 30 minutes post-procedure using the VAS: a 10 cm horizontal line, 0 = no pain and 10 = severe pain, with patients marking their self-perceived pain level)21. All data were recorded on a standardised collection sheet to ensure completeness and accuracy.
Statistical analysis
The collected data were entered into SPSS 26.0 software (IBM, Armonk, NY, USA) for analysis. Data normality was tested using the Kolmogorov–Smirnov method22. Normally distributed data were expressed as mean ± standard deviation, and comparisons between groups were performed using the t-test. Enumeration data were presented as cases or percentages, and the chi-squared (χ²) test was applied for group comparisons. Multivariate logistic regression analysis was performed, with colonoscopy completion status as the dependent variable (incomplete = 1, complete = 0) and variables with statistical significance in univariate analysis as independent variables (p < 0.05 considered significant). A nomogram model was developed using R software (version 4.2.0) with the rms package, with point values assigned to each independent risk factor based on regression coefficients. The nomogram was validated through bootstrap resampling (500 repetitions), evaluating predictive accuracy with the Hosmer–Lemeshow (H–L) deviation test and discriminative ability with the area under the curve (AUC) of the receiver operating characteristic curve. Clinical decision guidelines were established based on total risk scores, categorising patients into low-, moderate- and high-risk groups with corresponding intervention recommendations.
Quality control
All data collectors and endoscopists were trained on standardised procedures for data collection, examination performance and scale assessment to ensure consistency. Regular audits of collected data were conducted to check for completeness and accuracy, with discrepancies resolved immediately. Calibration of the measurement tools (tape measure, stopwatch, monitoring equipment) was checked before use.