Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06596317
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-04-12
Brief Title:
Impact of Indigo Carmine Pump Spraying on the Adenoma Detection Rate
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of Indigo Carmine Pump Spraying on the Adenoma Detection Rate A Prospective Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 patients 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 P005 was statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None