Detection and removal of polyps during colonoscopy is crucial for the prevention of colorectal cancer. Indigo carmine spraying up to the colonic mucosa could probably increase the adenoma detection rate. The traditional method of dye spraying with spraying catheter or syringe would consume a lot of time and dye volume. Now, the more convenient auxiliary water supply channel can be used to spray indigo carmine. In order to explore the clinical application value of spraying indigo carmine solution by auxiliary water channel in high-risk population, we performed a prospective, randomized controlled trial to compare adenoma detection rate of conventional colonoscopy and chromoendoscopy.
If patients scheduled for colonoscopy meet the inclusion criteria but not the exclusion criteria, he or she will be recruited to the study and randomized to one of two groups. Subjects in Group A (treatment group) will undergo colonoscopy with spraying indigo carmine solution during withdrawal process. Subjects in Group B (control group) will undergo a standard conventional colonoscopy without spraying any solution during withdrawal process. The traditional method of dye spraying with spraying catheter or syringe would consume a lot of time and dye volume. The solution spraying process was implemented by a water jet channel using auxiliary foot pump. Any lesions found during the procedure will be removed and sent for pathological examination. The investigator will record the patient's general information (such as gender, age, symptoms, body mass index, etc.), colonoscopy data (such as duration, dye amount, etc.), and lesion characteristics (such as location, morphology, histopathological classification, etc.). Randomization was done with SPSS program. All data were analyzed according to the ITT analysis, and the PP analysis was performed for all outcomes. Continuous variables were presented as means ± standard deviation (SD), and compared using the Student t test. Categorical data were expressed as number with percentage and analyzed using the chi-squared test or the Fisher exact test. All statistical analyses were performed using IBM SPSS Statistics or R Statistics, and 2-sided P\<0.05 was statistically significant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
330
Patients will undergo chromoendoscopy with spraying indigo carmine.
Patients will undergo conventional colonoscopy.
Qilu Hospital of Shandong University
Jinan, Shandong, China
adenoma detection rate(ADR)
ADR was calculated as the number of patients with at least one adenoma divided by the total number of patients. In other words, the adenoma detection rate of the sample was the proportion of patients with adenoma detected.
Time frame: procedure time
detected rate of different lesions
Lesions are classified according to their size, location, morphology and histopathology, the corresponding detection rate was calculated as secondary outcome measures.
Time frame: procedure time
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.