| Background and AimsColorectal cancer ranks third in terms of incidence but second in terms of mortality in malignant tumors worldwide.Globally,there are two major distinct precursor lesion pathways:the traditional adenoma-carcinoma pathway(also referred to as the chromosomal instability sequence)leading to 70-90%of colorectal cancers,and the serrated neoplasia pathway leading to 10-20%of colorectal cancers.It takes about 10-15 years for the final development of polyp to colorectal cancer,thus providing clinicians with an opportunity to intervene before cancer develops.Therefore,early screening for colorectal disease is an effective measure to reduce the incidence and mortality of colorectal cancer.Colonoscopy is considered the gold standard for the detection and treatment of colorectal lesions.One of the advantages of colonoscopy as a screening method is that,besides being the most accurate modality and its potential to reduce the incidence of CRC,it is a one-stage screening method in which precursor lesions and early cancers are detected and removed in the same procedure.Multiple studies have shown that colorectal cancer mortality can be reduced by more than 50%-60%after colonoscopy screening or polypectomy.However,the effectiveness of colonoscopy depends on the quality of intestinal preparation.Inadequate intestinal preparation will reduce the rate of adenoma detection and cecum intubation,prolong the examination time,and increase medical costs due to cancellation of colonoscopy and reduction of the time interval between examinations,thereby reducing the quality of the colonoscopy.Despite the importance of bowel preparation,multiple studies have reported a high rate of inadequate bowel preparation,ranging from 18%to 35%.There are many risk factors that affect the quality of intestinal preparation,such as:old age,obesity,chronic constipation,diabetes,history of abdominal or pelvic surgery,etc.The more these risk factors,the higher the risk of inadequate bowel preparation.Although the enhanced bowel preparation regimen can significantly improve the quality of intestinal preparation,at the same time,the intensive regimen is more likely to cause adverse events such as nausea,vomiting,dizziness,stomachache,thereby reducing patient’s tolerance and compliance.Therefore,identifying high-risk patients with inadequate bowel preparation and prescribing tailored bowel preparation regimen is the key to improving the quality of bowel preparation without increasing adverse events.So far,foreign scholars have developed three models to predict the risk factors for inadequate intestinal preparation,but these models have some limitations.In addition,the risk factors for inadequate bowel preparation included in these models are inconsistent.This shows that the risk factors of inadequate intestinal preparation are not completely consistent for different populations.Therefore,in order to explore the risk factors for inadequate intestinal preparation in the Chinese population,our research team developed a prediction model for inadequate intestinal preparation for the Chinese population in 2017.The effectiveness of this model has not been clinically verified.Therefore,this study aimed to evaluate the effectiveness of the model for individualized guidance in bowel preparation before colonoscopy through a randomized controlled trial to better guide the individualized bowel preparation of the Chinese population.MethodsPatients aged 18-75 years undergoing colonoscopy were enrolled in this study and patients who met the exclusion criteria were excluded.Basic demographic data and predictors in predictive models are recorded at colonoscopy appointment.Patients were divided into high-risk and low-risk according to the cutoff value of 3 points.All enrolled patients were randomly assigned to tailored or control group by opening opaque envelopes.In the tailored group,high-risk patients were given 4L PEG and low-risk patients were given 2L PEG.All patients in the control group were given 2L PEG.Before colonoscopy,the dose of laxatives,adverse events,discomfort score and willingness to repeat bowel preparation were recorded for each patient.Colonoscopy is performed by experienced colonoscopy physician(more than 1,000 colonoscopy per year).The quality of bowel preparation,cecal intubation time,withdrawal time,the presence,quantity and size of polyps were recorded during colonoscopy.All detected polyps were removed endoscopically or biopsied.The primary endpoint of this study was the quality of bowel preparation assessed by the Boston Bowel Preparation Scale(BBPS).Secondary endpoints included cecal intubation time,withdrawal time,polyp detection rate,adenoma detection rate,patient compliance,tolerance,and acceptability.SPSS 25.0 was used for data analysis.Continuous variables were expressed as mean±standard deviation and analyzed by Student-t test.Categorical variables were expressed as numbers and percentages,and analyzed by Pearson’s chi-square test or Fisher’s exact test.P<0.05 was considered statistically significant.ResultsA total of 429 patients were randomly assigned into the tailored group(n=214)and control group(n=215).All baseline characteristics and predictors of inadequate bowel preparation were balanced between the two groups.In the ITT analysis,the rate of adequate bowel preparation in the tailored group was significantly higher than that in the control group,both in the general population(79.91%vs.70.23%,P=0.021)and high-risk population(78.69%vs.48.39%,P<0.001).No significant difference was observed in the low-risk population(80.39%vs.79.08%,P=0.776).The ADR of the individualized group was significantly higher than that in the control group,both in the general population(33.18%vs.21.86%,P=0.009)and high-risk population(44.26%vs.19.35%,P=0.003).No significant difference was observed in the low-risk population(28.76%vs.22.88%,P=0.240).In the PP analysis,the rate of adequate bowel preparation in the tailored group was significantly higher than that in the control group,both in the general population(84.65%vs.75.50%,P=0.022)and high-risk population(84.21%vs.53.57%,P<0.001).No significant difference was observed in the low-risk population(84.83%vs.84.03%,P=0.851).The ADR of the individualized group was significantly higher than that in the control group,both in the general population(35.15%vs.23.50%,P=0.010)and high-risk population(47.37%vs.21.43%,P=0.004).No significant difference was observed in the low-risk population(30.34%vs.24.31%,P=0.249).The total BBPS scores were significantly higher in the tailored group than that in the control group,both in the general population(6.64±1.28 vs.6.32±1.41,P=0.016)and high-risk population(6.86 ± 1.27 vs.5.66 ± 1.33,P<0.001).No difference was observed in the low-risk population(6.56±1.27 vs.6.58±1.37,P=0.909).The cecal intubation time(9.22±5.38 vs.8.82 ± 4.81,P=0.434)and withdrawal time(6.98± 2.00 vs.6.80 ± 1.96,P=0.361)did not differ between the two groups.No statistical difference was observed in terms of patients’ compliance,tolerance,and acceptability(P>0.05).ConclusionsTailored bowel preparation under the guidance of the predictive model for inadequate bowel preparation in the Chinese population has significantly improved the quality of bowel preparation,polyp detection rate,and adenoma detection rate without affecting patient’s compliance,tolerance,and acceptability.This model allows clinicians to easily and effectively predict the risk of inadequate bowel preparation,and it is of great significance to clinically guide the Chinese population in intestinal preparation and improve the overall quality of bowel preparation. |
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