Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05712304
Status:
RECRUITING
Last Update Posted:
2023-02-16
First Post:
2023-01-25
Brief Title:
Impact of SE of the Proximal Colon on the AMR
Sponsor:
Third Peoples Hospital of Jingdezhen City
Organization:
Third Peoples Hospital of Jingdezhen City
Study Overview
Official Title:
Impact of the Second vs Conventional Examination of the Proximal Colon on Adenoma Miss Rate a Prospective Randomized Tandem Trial
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Studies have demonstrated that the second examination of the proximal colon can significantly increase the proximal ADRThis study aimed to determine the impact of second examination of the proximal colon on AMR compared to conventional examinationConsecutive patients aged 40-75years undergoing colonoscopy for screeningTandem withdrawal was used in the proximal colonPatients were randomly assigned to either the second examinationSE or the conventional examinationCE groupThe primary outcome measure was proximal AMRdefined as the number of proximal adenomas detected in the second passCE groupor the third passSE groupdivided by the total number of proximal adenomas detected during the tandem colonoscopy
Detailed Description:
Colonoscopy is routinely performed for detection and removal of colorectal adenomas thereby preventing colorectal cancerCRCThe adenoma miss ratesAMR still ranges between 26-62and missed adenomas may contribute to the development of interval CRCTherefore there is currently considerable interest in improving AMR during a colonoscopyThe second examination has recently attracted increasing attentionsince it only requires a relatively short procedure time and does not require any specialized equipmentThus we performed an randomized controlled trial RCT in patients undergoing colonoscopy for screening to determine the impact of second examination of the proximal colon on AMR compared to conventional examination
This study aimed to determine the impact of second examination of the proximal colon on AMR compared to conventional examinationConsecutive patients aged 40-75years undergoing colonoscopy for screeningPatients were excluded if they failed cecal intubation prior colorectal resection inadequate bowel preparation quality Boston Bowel Preparation Scale BBPSscores 2 in any segment of the colon inflammatory bowel disease or intestinal tuberculosis familial polyposis syndrome coagulation dysfunction or polyp retrieval failure
Consecutive patients aged 40-75years undergoing colonoscopy for screeningTandem withdrawal was used in the proximal colonThe colonoscope was inserted in a standard manner After successful insertion in the cecum the colonoscope was slowly withdrawn to the splenic flexure and the mucosa was carefully observed the polyps that were found were removed for histopathologic examinationfirst passOnce the splenic flexure was reached the position of splenic flexure was marked by creating a suction mark or taking a small biopsy Subsequently the colonoscope was advanced to the cecum again additional polyps were removed from the proximal colon during the second withdrawalsecond pass When the colonoscope completed the two forward view examination of the proximal colon defined as proximal to the splenic flexure patients were randomly assigned to either the second examinationSE or the conventional examinationCE group The randomization sequence was computer-generated and concealed in sequentially numbered sealed opaque envelopes at this moment the envelope was opened For patients in the SE group the colonoscope was reinserted into the cecum additional polyps were removed from the proximal colon during the third withdrawallthird pass and the remainder of the colon from splenic flexure to rectum was examined in a standard manner For patients in the CE group the colonoscope was withdrawn directly from the splenic flexure to the rectum and polyps that were found were removed Multiple diminutive hyperplastic polyps 5 mm in the sigmoid colon and rectum were not subjected to removal and only one representative polyp biopsy was analyzed We recorded all adverse events at the time of the colonoscopy and for one week there after The cecal intubation time and withdrawal time were recorded by an assistant with a stopwatch The time for polypectomy and biopsy were excluded from the withdrawal time The primary outcome measure was proximal AMRdefined as the number of proximal adenomas detected in the second passCE groupor the third passSE groupdivided by the total number of proximal adenomas detected during the tandem colonoscopy
This study aimed to determine the impact of second examination of the proximal colon on AMR compared to conventional examinationConsecutive patients aged 40-75years undergoing colonoscopy for screeningPatients were excluded if they failed cecal intubation prior colorectal resection inadequate bowel preparation quality Boston Bowel Preparation Scale BBPSscores 2 in any segment of the colon inflammatory bowel disease or intestinal tuberculosis familial polyposis syndrome coagulation dysfunction or polyp retrieval failure
Consecutive patients aged 40-75years undergoing colonoscopy for screeningTandem withdrawal was used in the proximal colonThe colonoscope was inserted in a standard manner After successful insertion in the cecum the colonoscope was slowly withdrawn to the splenic flexure and the mucosa was carefully observed the polyps that were found were removed for histopathologic examinationfirst passOnce the splenic flexure was reached the position of splenic flexure was marked by creating a suction mark or taking a small biopsy Subsequently the colonoscope was advanced to the cecum again additional polyps were removed from the proximal colon during the second withdrawalsecond pass When the colonoscope completed the two forward view examination of the proximal colon defined as proximal to the splenic flexure patients were randomly assigned to either the second examinationSE or the conventional examinationCE group The randomization sequence was computer-generated and concealed in sequentially numbered sealed opaque envelopes at this moment the envelope was opened For patients in the SE group the colonoscope was reinserted into the cecum additional polyps were removed from the proximal colon during the third withdrawallthird pass and the remainder of the colon from splenic flexure to rectum was examined in a standard manner For patients in the CE group the colonoscope was withdrawn directly from the splenic flexure to the rectum and polyps that were found were removed Multiple diminutive hyperplastic polyps 5 mm in the sigmoid colon and rectum were not subjected to removal and only one representative polyp biopsy was analyzed We recorded all adverse events at the time of the colonoscopy and for one week there after The cecal intubation time and withdrawal time were recorded by an assistant with a stopwatch The time for polypectomy and biopsy were excluded from the withdrawal time The primary outcome measure was proximal AMRdefined as the number of proximal adenomas detected in the second passCE groupor the third passSE groupdivided by the total number of proximal adenomas detected during the tandem colonoscopy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None