Detailed Information on Publication Record
2014
Cílený screening kolorektálního karcinomu u diabetiků 2. typu a osob s vysokým kardiovaskulárním rizikem - První průbežné výsledky multicentrické prospektivní studie
SUCHÁNEK, Š., Ondřej MÁJEK, T. GREGA, Ondřej NGO, P. MINÁRIKOVÁ et. al.Basic information
Original name
Cílený screening kolorektálního karcinomu u diabetiků 2. typu a osob s vysokým kardiovaskulárním rizikem - První průbežné výsledky multicentrické prospektivní studie
Name (in English)
Targeted colorectal cancer screening in type 2 diabetes patients and high cardiovascular risk patients - First interim results of a multicenter prospective study
Authors
SUCHÁNEK, Š. (203 Czech Republic), Ondřej MÁJEK (203 Czech Republic, guarantor, belonging to the institution), T. GREGA (203 Czech Republic), Ondřej NGO (203 Czech Republic, belonging to the institution), P. MINÁRIKOVÁ (203 Czech Republic), N. BROGYUK (203 Czech Republic), B. SEIFERT (203 Czech Republic), Ladislav DUŠEK (203 Czech Republic, belonging to the institution) and M. ZAVORAL (203 Czech Republic)
Edition
Gastroenterologie a hepatologie, Praha, Ambit Media, 2014, 1804-7874
Other information
Language
Czech
Type of outcome
Článek v odborném periodiku
Field of Study
10103 Statistics and probability
Country of publisher
Czech Republic
Confidentiality degree
není předmětem státního či obchodního tajemství
RIV identification code
RIV/00216224:14110/14:00080174
Organization unit
Faculty of Medicine
Keywords in English
Adenoma; Bowel preparation; Colorectal cancer; Coronary heart disease; Metabolic risk; Screening; Sulfate salts solution; Type 2 diabetes
Tags
Tags
Reviewed
Změněno: 22/1/2015 15:40, Soňa Böhmová
V originále
The National Colorectal Cancer (CRC) Screening Program has been running in the Czech Republic (CR) since 2000 and is focused on asymptomatic individuals with an average risk of this malignancy. However, according to some studies, there is evidence of a higher CRC risk in patients with metabolic diseases. Therefore, the Czech multicenter prospective study was launched adein 2013 to verify this hypothesis. This text presents the first interim results, focusing on a sub-study on bowel preparation. The main aim of the study is to verify the assumption that people with increased cardiovascular risk with SCORE > 10% (ischemic heart disease - IHD) and diabetes mellitus type 2 (DM2) in the Czech population bear a higher risk of colorectal neoplasia (cancer; advanced adenoma - size >/= 10 mm, high grade dysplasia, villous character). The secondary aim is to compare the effectiveness of different types of bowel preparation before colonoscopy. Initially, a pilot project evaluating the efficacy of sulfate salt solution (product Eziclen) was performed. Material and methods: The study will be running from 2013 to 2015. The project will involve 2,000 individuals (1,000 in the control group and 1,000 in the target group). All patients (aged 45-75 years) meet the condition of the "screening" population (asymptomatic, without family or personal history of colorectal neoplasia) and are examined by colonoscopy at eight centers for colonoscopy screening. The primary outcome is the prevalence of colorectal neoplasia in the target and the control group. In the bowel preparation pilot project, the effectiveness of bowel cleansing (4-point scale A-D) and its safety (changes in clinical biochemical values) was assessed. Results: 640 individuals have been enrolled in the main study so far. In 44% of them (281 individuals; 167 men - 59%; 114 women - 41%; mean age 59 years) the complete data have been already recorded. The observed prevalence of adenomas was higher in the target group than in the control group (41 vs 29%, p = 0,034), both for men (45 vs 37%) and women (33 vs 21%); however, comparisons stratified by sex did not reach statistical significance. In the case of advanced adenomas and carcinomas the differences were not statistically significant. In the target group, more adenomas and advanced adenomas were diagnosed in patients with a combination of IHD and DM2 (55, i.e. 13%), than in patients with isolated ischemic heart disease (40, i.e. 12%) or DM2 (32, i.e. 5%). In the bowel preparation pilot project, 100 individuals were enrolled. Excellent (grade A) or adequate (grade A + B) bowel preparation was reached in 65% and 90% of the individuals, respectively. The level of bowel cleansing was significantly increased by using split dose regime. High detection of adenomas (57%) was recorded. No significant clinical changes in blood mineral levels before and after colonoscopy were observed. Conclusion: According to the interim study results, patients with a higher metabolic risk (cardiovascular; diabetes mellitus type 2) have a statistically significantly higher risk of adenomatous polyps; however, the study results are inconclusive and final conclusions will only be available after enrolling the total planned number of patients. The new bowel preparation method using sulfate salts solution is safe and effective, particularly when the split dose regime is used.
In English
The National Colorectal Cancer (CRC) Screening Program has been running in the Czech Republic (CR) since 2000 and is focused on asymptomatic individuals with an average risk of this malignancy. However, according to some studies, there is evidence of a higher CRC risk in patients with metabolic diseases. Therefore, the Czech multicenter prospective study was launched adein 2013 to verify this hypothesis. This text presents the first interim results, focusing on a sub-study on bowel preparation. The main aim of the study is to verify the assumption that people with increased cardiovascular risk with SCORE > 10% (ischemic heart disease - IHD) and diabetes mellitus type 2 (DM2) in the Czech population bear a higher risk of colorectal neoplasia (cancer; advanced adenoma - size >/= 10 mm, high grade dysplasia, villous character). The secondary aim is to compare the effectiveness of different types of bowel preparation before colonoscopy. Initially, a pilot project evaluating the efficacy of sulfate salt solution (product Eziclen) was performed. Material and methods: The study will be running from 2013 to 2015. The project will involve 2,000 individuals (1,000 in the control group and 1,000 in the target group). All patients (aged 45-75 years) meet the condition of the "screening" population (asymptomatic, without family or personal history of colorectal neoplasia) and are examined by colonoscopy at eight centers for colonoscopy screening. The primary outcome is the prevalence of colorectal neoplasia in the target and the control group. In the bowel preparation pilot project, the effectiveness of bowel cleansing (4-point scale A-D) and its safety (changes in clinical biochemical values) was assessed. Results: 640 individuals have been enrolled in the main study so far. In 44% of them (281 individuals; 167 men - 59%; 114 women - 41%; mean age 59 years) the complete data have been already recorded. The observed prevalence of adenomas was higher in the target group than in the control group (41 vs 29%, p = 0,034), both for men (45 vs 37%) and women (33 vs 21%); however, comparisons stratified by sex did not reach statistical significance. In the case of advanced adenomas and carcinomas the differences were not statistically significant. In the target group, more adenomas and advanced adenomas were diagnosed in patients with a combination of IHD and DM2 (55, i.e. 13%), than in patients with isolated ischemic heart disease (40, i.e. 12%) or DM2 (32, i.e. 5%). In the bowel preparation pilot project, 100 individuals were enrolled. Excellent (grade A) or adequate (grade A + B) bowel preparation was reached in 65% and 90% of the individuals, respectively. The level of bowel cleansing was significantly increased by using split dose regime. High detection of adenomas (57%) was recorded. No significant clinical changes in blood mineral levels before and after colonoscopy were observed. Conclusion: According to the interim study results, patients with a higher metabolic risk (cardiovascular; diabetes mellitus type 2) have a statistically significantly higher risk of adenomatous polyps; however, the study results are inconclusive and final conclusions will only be available after enrolling the total planned number of patients. The new bowel preparation method using sulfate salts solution is safe and effective, particularly when the split dose regime is used.
Links
| NT13673, research and development project |
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