Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333392
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-20
Brief Title:
Total Underwater Colonoscopy TUC for Improved Colorectal Cancer Screening A Randomized Controlled Trial
Sponsor:
Vestre Viken Hospital Trust
Organization:
Vestre Viken Hospital Trust
Study Overview
Official Title:
Total Underwater Colonoscopy TUC for Improved Colorectal Cancer Screening A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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 the third most diagnosed cancer and second most common cause of cancer death CRCs develop from precursors like adenomas about 70 of CRCs or serrated lesions SSLs about 25-30 of CRCs Colonoscopy is the cornerstone in CRC screening in screening programmes often as a work-up examination after a positive primary screening test such as faecal immunochemical test FIT Norway and Sweden have recently launched a nationwide faecal haemoglobin CRC screening programmes Recently both a Dutch and an Austrian study showed that SSL detection rate SSLDR is inversely correlated to CRC at follow-up Consequently improved SSLDR can reduce the risk of post-colonoscopy CRC SSLs are typically located in the right colon They are flat with indistinctive boarders and consequently easily missed or incompletely resected A Norwegian study showed incomplete resection of 40 of proximal SSLs The prevalence of SSLs is higher in women than in men with women being on a threefold risk of developing CRC from SSLs It seems like post-colonoscopy CRC more often is caused by SSLs than by adenomas Total underwater colonoscopy TUC is a technique replacing conventional CO2 insufflation by water infusion to distend the lumen and visualise the mucosa during withdrawal of the colonoscope and simultaneously removal of water There are several reasons to advocate TUC
1 SSLs will be more visible as they float on the submucosa and contract into the lumen while full distension by gas stretches the mucosa making detection of flat lesions more difficult
2 Water works like a magnifying lens making detection and detailed characterisation of lesions easier
3 uEMR is eased
4 Improved bowel cleansing
The goal of this clinical trial is to compare colonoscopy outcomes for standard gas CO2 insufflation and TUC during withdrawal in patients participating in colonoscopy in the Norwegian and Swedish colorectal cancer screening programme after a positive fecal immunochemical test
The overarching research questions of the present trial is whether colonoscopy outcomes are improved when CO2 insufflation is replaced by TUC during withdrawal and whether the new technique reduces the ecological footprint of the colonoscopy examination
The project has five main hypotheses
1 TUC is superior to the standard approach CO2 withdrawal regarding detection of proximal SSLs
2 TUC increases the rate of complete resection of lesions gt 10mm
3 TUC reduces the rate of painful colonoscopies and vasovagal reactions
4 TUC reduces the health care costs by reduced use of single use accessories and reduced number of redundant colonoscopies to obtain polypfree colon
5 TUC reduces the carbon footprint by reduced use of single use accessories
If TUC is superior to gas insufflation the technique may be implemented rapidly since the technique is easy to learn This study will increase endoscopy competence at participating centres The centres are involved in national colonoscopy training programs so the technique will quickly be passed on to other hospitals and screening centres
The trial can be linked to three of the Global Goals
Good health and well-being The increased detection and improved complete removal of sessile serrated lesions can subsequently decrease the risk of CRC and CRC mortality during follow-up TUC will probably reduce the rate of painful procedures and vasovagal reactions and thus increase the acceptance of a screening programme Consequently the project can contribute significantly to improve screening effectiveness in Norway and Sweden particularly in women women have a higher risk for SSLs and a higher risk of colorectal cancer developing from this type of precursor
Gender equality Women have a similar lifetime risk for CRC as men but less benefit of screening regardless of whether they are screened by sigmoidoscopy FIT or colonoscopy The reason is probably missed sessile serrated lesions in the proximal colon If TUC improves SSLDR and complete lesion resection this may lead to an equal benefit from CRC screening for women and men Women have also a higher risk of discomfort and pain during colonoscopy than men It has been shown that women prefer non-invasive screening modalities potentially to avoid pain during colonoscopy even if colonoscopy may be the most beneficial screening method for women If TUC reduces the rate of painful colonoscopies it can reduce womens barriers to attend screening
Responsible consumption and production The TUC technique will also reduce the ecological footprint of colonoscopy activity due to reduced consumption of single use accessories and reduced number of colonoscopies to achieve polyp free colon Furthermore the cost for the health care system will be substantially reduced
1 SSLs will be more visible as they float on the submucosa and contract into the lumen while full distension by gas stretches the mucosa making detection of flat lesions more difficult
2 Water works like a magnifying lens making detection and detailed characterisation of lesions easier
3 uEMR is eased
4 Improved bowel cleansing
The goal of this clinical trial is to compare colonoscopy outcomes for standard gas CO2 insufflation and TUC during withdrawal in patients participating in colonoscopy in the Norwegian and Swedish colorectal cancer screening programme after a positive fecal immunochemical test
The overarching research questions of the present trial is whether colonoscopy outcomes are improved when CO2 insufflation is replaced by TUC during withdrawal and whether the new technique reduces the ecological footprint of the colonoscopy examination
The project has five main hypotheses
1 TUC is superior to the standard approach CO2 withdrawal regarding detection of proximal SSLs
2 TUC increases the rate of complete resection of lesions gt 10mm
3 TUC reduces the rate of painful colonoscopies and vasovagal reactions
4 TUC reduces the health care costs by reduced use of single use accessories and reduced number of redundant colonoscopies to obtain polypfree colon
5 TUC reduces the carbon footprint by reduced use of single use accessories
If TUC is superior to gas insufflation the technique may be implemented rapidly since the technique is easy to learn This study will increase endoscopy competence at participating centres The centres are involved in national colonoscopy training programs so the technique will quickly be passed on to other hospitals and screening centres
The trial can be linked to three of the Global Goals
Good health and well-being The increased detection and improved complete removal of sessile serrated lesions can subsequently decrease the risk of CRC and CRC mortality during follow-up TUC will probably reduce the rate of painful procedures and vasovagal reactions and thus increase the acceptance of a screening programme Consequently the project can contribute significantly to improve screening effectiveness in Norway and Sweden particularly in women women have a higher risk for SSLs and a higher risk of colorectal cancer developing from this type of precursor
Gender equality Women have a similar lifetime risk for CRC as men but less benefit of screening regardless of whether they are screened by sigmoidoscopy FIT or colonoscopy The reason is probably missed sessile serrated lesions in the proximal colon If TUC improves SSLDR and complete lesion resection this may lead to an equal benefit from CRC screening for women and men Women have also a higher risk of discomfort and pain during colonoscopy than men It has been shown that women prefer non-invasive screening modalities potentially to avoid pain during colonoscopy even if colonoscopy may be the most beneficial screening method for women If TUC reduces the rate of painful colonoscopies it can reduce womens barriers to attend screening
Responsible consumption and production The TUC technique will also reduce the ecological footprint of colonoscopy activity due to reduced consumption of single use accessories and reduced number of colonoscopies to achieve polyp free colon Furthermore the cost for the health care system will be substantially reduced
Detailed Description:
None
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