Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06186778
Status:
COMPLETED
Last Update Posted:
2024-06-10
First Post:
2023-11-25
Brief Title:
The Impact of Repeated Colonoscopic Insert Method on the Detection Rate of Adenomas in the Sigmoid Colon
Sponsor:
Jianning Yao
Organization:
The First Affiliated Hospital of Zhengzhou University
Study Overview
Official Title:
The Impact of Repeated Colonoscopic Insert Method on the Detection Rate of Adenomas in the Sigmoid Colon
Status:
COMPLETED
Status Verified Date:
2024-06
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:
Colorectal cancer CRC is a malignant tumour originating from the colorectal mucosal epithelium with rising incidence and mortality rates Approximately 90 of CRC develops from colorectal polyps which are considered precancerous lesions of CRC especially adenomatous polyps If removed endoscopically during the polyp stage 70-90 of CRC can be prevented However current colonoscopy examinations have a high miss rate for polyps Studies have shown that the miss rates for polyps and adenomas after colonoscopy can reach 22-28 and 12-26 respectively
The 2014 Chinese Guidelines for Early Screening and Endoscopic Diagnosis and Treatment of Colorectal Cancer mentions that the observation method during colonoscopy starts from the rectum and progresses forward to the cecum with observations made during withdrawal However in actual clinical practice it is found that single withdrawal observation is not enough as this examination approach is prone to many missed polyps The likely reason is that the colon is in a compressed state during withdrawal observation Single-operator colonoscopy is currently the mainstream insertion method internationally and the essence of the single-operator technique is short-axis reductions meaning that the colonoscope maintains a straight configuration throughout the entire examination The average adult colon length is about 15m but the distance reached by the colonoscope during the single-operator technique is often between 70-80cm indicating compression of the colon In addition colonic folds become more dense when compressed making it easier for lesions like polyps to hide within or near folds leading to misses
The sigmoid colon with the most turns in the entire large intestine is also the part most prone to compression during colonoscopy insertion Correspondingly it is also more prone to misses during withdrawal observation Although some scholars proposed repeating withdrawal to improve lesion detection rates whether it is performed twice or three times only compressed colons are observed In actual clinical work many polyps can only be found during insertion The investigators propose performing a second insert specifically for the easily compressed sigmoid colon During the second insert the short-axis reduction technique should not be used Instead the folds should be deliberately advanced into which helps fully extend the compressed sigmoid colon to shallow or eliminate the folds allowing observation during advancement to achieve effects beyond multiple withdrawals finding hidden lesions within or near folds to improve colonoscopy quality Therefore to explore whether observing during a second sigmoid colon advancement can further improve the adenoma detection rate to improve colonoscopy quality and reduce interval cancers the investigators conducted this study
The 2014 Chinese Guidelines for Early Screening and Endoscopic Diagnosis and Treatment of Colorectal Cancer mentions that the observation method during colonoscopy starts from the rectum and progresses forward to the cecum with observations made during withdrawal However in actual clinical practice it is found that single withdrawal observation is not enough as this examination approach is prone to many missed polyps The likely reason is that the colon is in a compressed state during withdrawal observation Single-operator colonoscopy is currently the mainstream insertion method internationally and the essence of the single-operator technique is short-axis reductions meaning that the colonoscope maintains a straight configuration throughout the entire examination The average adult colon length is about 15m but the distance reached by the colonoscope during the single-operator technique is often between 70-80cm indicating compression of the colon In addition colonic folds become more dense when compressed making it easier for lesions like polyps to hide within or near folds leading to misses
The sigmoid colon with the most turns in the entire large intestine is also the part most prone to compression during colonoscopy insertion Correspondingly it is also more prone to misses during withdrawal observation Although some scholars proposed repeating withdrawal to improve lesion detection rates whether it is performed twice or three times only compressed colons are observed In actual clinical work many polyps can only be found during insertion The investigators propose performing a second insert specifically for the easily compressed sigmoid colon During the second insert the short-axis reduction technique should not be used Instead the folds should be deliberately advanced into which helps fully extend the compressed sigmoid colon to shallow or eliminate the folds allowing observation during advancement to achieve effects beyond multiple withdrawals finding hidden lesions within or near folds to improve colonoscopy quality Therefore to explore whether observing during a second sigmoid colon advancement can further improve the adenoma detection rate to improve colonoscopy quality and reduce interval cancers the investigators conducted this study
Detailed Description:
Colorectal cancer CRC is a malignant tumour originating from the colorectal mucosal epithelium with rising incidence and mortality rates Currently CRC ranks third in incidence and second in mortality among all cancers worldwide making it the leading cancer in terms of global incidence and mortality Approximately 90 of CRC develops from colorectal polyps which are considered precancerous lesions of CRC especially adenomatous polyps If removed endoscopically during the polyp stage 70-90 of CRC can be prevented However current colonoscopy examinations have a high miss rate for polyps Studies have shown that the miss rates for polyps and adenomas after colonoscopy can reach 22-28 and 12-26 respectively
The 2014 Chinese Guidelines for Early Screening and Endoscopic Diagnosis and Treatment of Colorectal Cancer mentions that the observation method during colonoscopy starts from the rectum and progresses forward to the cecum with observations made during withdrawal from the cecum ascending colon transverse colon descending colon sigmoid colon to the rectum Current quality control of colonoscopy mainly focuses on controlling withdrawal time exceeding 6 minutes controlling cecal intubation rate and ensuring adenoma detection rate without specific requirements on the observation method However in actual clinical practice it is found that single withdrawal observation is not enough as this examination approach is prone to many missed polyps The likely reason is that the colon is in a compressed state during withdrawal observation Single-operator colonoscopy is currently the mainstream insertion method internationally and the essence of the single-operator technique is short-axis reductions meaning that the colonoscope maintains a straight configuration throughout the entire examination The average adult colon length is about 15m but the distance reached by the colonoscope during the single-operator technique is often between 70-80cm indicating compression of the colon In addition colonic folds become more dense when compressed making it easier for lesions like polyps to hide within or near folds leading to misses Currently in the clinical practice of colonoscopy only withdrawal observation is performed and only once on a compressed colon Many lesions can be easily missed
The sigmoid colon with the most turns in the entire large intestine is also the part most prone to compression during colonoscopy insertion Correspondingly it is also more prone to misses during withdrawal observation Although some scholars proposed repeating withdrawal to improve lesion detection rates whether it is performed twice or three times only compressed colons are observed In actual clinical work many polyps can only be found during advancement The investigators propose performing a second advancement specifically for the easily compressed sigmoid colon During the second advancement the short-axis reduction technique should not be used Instead the folds should be deliberately advanced into which helps fully extend the compressed sigmoid colon to shallow or eliminate the folds allowing observation during advancement to achieve effects beyond multiple withdrawals finding hidden lesions within or near folds to improve colonoscopy quality Therefore to explore whether observing during a second sigmoid colon advancement can further improve the adenoma detection rate ADR to improve colonoscopy quality and reduce interval cancers the investigators conducted this study
The 2014 Chinese Guidelines for Early Screening and Endoscopic Diagnosis and Treatment of Colorectal Cancer mentions that the observation method during colonoscopy starts from the rectum and progresses forward to the cecum with observations made during withdrawal from the cecum ascending colon transverse colon descending colon sigmoid colon to the rectum Current quality control of colonoscopy mainly focuses on controlling withdrawal time exceeding 6 minutes controlling cecal intubation rate and ensuring adenoma detection rate without specific requirements on the observation method However in actual clinical practice it is found that single withdrawal observation is not enough as this examination approach is prone to many missed polyps The likely reason is that the colon is in a compressed state during withdrawal observation Single-operator colonoscopy is currently the mainstream insertion method internationally and the essence of the single-operator technique is short-axis reductions meaning that the colonoscope maintains a straight configuration throughout the entire examination The average adult colon length is about 15m but the distance reached by the colonoscope during the single-operator technique is often between 70-80cm indicating compression of the colon In addition colonic folds become more dense when compressed making it easier for lesions like polyps to hide within or near folds leading to misses Currently in the clinical practice of colonoscopy only withdrawal observation is performed and only once on a compressed colon Many lesions can be easily missed
The sigmoid colon with the most turns in the entire large intestine is also the part most prone to compression during colonoscopy insertion Correspondingly it is also more prone to misses during withdrawal observation Although some scholars proposed repeating withdrawal to improve lesion detection rates whether it is performed twice or three times only compressed colons are observed In actual clinical work many polyps can only be found during advancement The investigators propose performing a second advancement specifically for the easily compressed sigmoid colon During the second advancement the short-axis reduction technique should not be used Instead the folds should be deliberately advanced into which helps fully extend the compressed sigmoid colon to shallow or eliminate the folds allowing observation during advancement to achieve effects beyond multiple withdrawals finding hidden lesions within or near folds to improve colonoscopy quality Therefore to explore whether observing during a second sigmoid colon advancement can further improve the adenoma detection rate ADR to improve colonoscopy quality and reduce interval cancers the investigators conducted this study
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