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NCT04921488
Artificial Intelligence (AI) to predict the histology of polyps per colonoscopy, offers a promising solution to reduce variation in colonoscopy performance. This new and innovative non-invasive technology will improve the quality of screening colonoscopies, and reduce the costs of colorectal cancer screening. The aim of the study is to performed a cross-sectional, multi-center study evaluating the diagnostic performance of the CAD EYE automatic characterization system for the histology of colonic polyps in colorectal cancer screening colonoscopy.
NCT07526103
Patients with diabetes have less effective colonoscopy preparation when compared to nondiabetic patients. This leads to the possibility of missed polyps, longer procedural time and patient dissatisfaction. Furthermore, the peri-colonoscopy period has been associated with increased risk of hypoglycemic events given the required change in diet and possible changes in antihyperglycemic medication regime, though this area is not well studied. Studies have found that same day preparation for colonoscopy allowed for comparable bowel visualization to split dosing. Pairing this with a low fiber diet permitted the day prior to colonoscopy, the extent of changes to routine and diet within a patient with diabetes day for colonoscopy preparation is minimized and could reduce risk of side effects and hypoglycemia, while also ensuring adequate bowel preparation. This study tests the hypothesis that creating a diabetic specific protocol (permitting a low fibre diet the day prior to colonoscopy and using same day preparation) will result in fewer hypoglycemic events and more adequate quality preparation in comparison to a conventional 2L PEG split day preparation with dietary restrictions in patients with diabetes.
NCT07541924
Colonoscopy is the cornerstone for colorectal cancer screening, diagnosis, and post-treatment surveillance. Procedural quality is influenced by patient anatomy, particularly variations in colonic configuration such as sigmoid redundancy, looping, and low-lying transverse colon. These features prolong insertion time, increase patient discomfort, and elevate physician workload. Evidence suggests that prior CT imaging can provide objective and individualized information on colonic anatomy-such as redundancy, angulation, and tortuosity-potentially predicting procedural difficulty. However, existing studies are mainly retrospective or descriptive, lacking prospective randomized evidence on clinical utility. This single-blind, randomized controlled trial evaluates whether image-assisted colonoscope insertion, based on pre-existing abdominal/pelvic CT scans, can improve cecal intubation time, enhance patient experience, reduce operator workload, and improve overall examination quality compared with standard colonoscopy.
NCT06776913
The goal of this study is to test which colonoscope works best in people who are above a certain body mass index. Currently, both pediatric and adult colonoscopes are accepted as standard treatments in colonoscopies. Endoscopist pick which one to use based on personal preference and what is available.
NCT07419204
Introduction and Objectives Patients diagnosed with Inflammatory Bowel Disease (IBD) carry a significantly elevated risk for opportunistic infections and the reactivation of latent pathogens, most notably Cytomegalovirus (CMV). CMV reactivation in the colonic mucosa can exacerbate underlying IBD, leading to poor clinical outcomes and resistance to standard immunosuppressive therapies. This prospective study was designed with a multi-faceted objective: To evaluate and quantify the CMV viral load within the intestinal tissues of a pediatric cohort, comprising both IBD and non-IBD control groups. To identify specific clinical and biological factors associated with increased CMV detection. To establish potential diagnostic threshold values for CMV viral load in the colonic mucosa, with a primary focus on Ulcerative Colitis (UC) patients-where CMV colitis is most prevalent-as well as patients with other intestinal pathologies. To perform a comparative analysis of diagnostic modalities, specifically evaluating the diagnostic value of histopathology, serum Cytomegalovirus-Polymerase Chain Reaction (CMV-PCR), and tissue CMV-PCR. 2\. Methodology and Procedural Framework The research was conducted at the Pediatric Gastroenterology Endoscopy Unit between May 2022 and March 2024. The study population consisted of pediatric patients undergoing scheduled colonoscopies. Biopsy Protocol: During the endoscopic procedure, two biopsy samples were systematically obtained from the rectal mucosa. For patients presenting with mucosal ulcers, samples were extracted directly from the ulcerated site; in patients with macroscopically normal mucosa, samples were taken from standard rectal tissue. Contamination Prevention: To ensure molecular integrity and prevent cross-contamination, separate forceps were utilized for samples intended for PCR analysis versus those intended for histopathology. Laboratory Analysis: Concurrently, venous blood samples were collected to analyze CMV serology (anti-CMV Immunoglobulin G \[IgG\] / Immunoglobulin M \[IgM\]) and serum CMV-PCR. In cases of IgM positivity, CMV IgG avidity tests were performed to distinguish between primary infection and reactivation. Diagnostic Criteria: A diagnosis of CMV colitis was established based on clinical symptoms, histopathological evidence (Hematoxylin and Eosin \[HE\] staining and Immunohistochemistry \[IHC\]), and a serum CMV-PCR threshold of ≥1000 copies/mL. 3\. Molecular and Histopathological Techniques Deoxyribonucleic Acid (DNA) Extraction: Tissue DNA was extracted using the QIAamp DNA Mini Kit, involving overnight incubation at 56°C for complete tissue digestion. Plasma DNA extraction was automated via the QIAsymphony SP platform. Internal controls were used in every run to validate extraction efficiency. Real-Time Polymerase Chain Reaction (Real-Time PCR): Amplification targeted a 105-bp region of the CMV genome using the Artus CMV QS-RGQ Kit. The assay provided a wide linear range (79.4 to 1×10⁸ copies/mL) with a high analytical sensitivity of 42.5 copies/mL. Results were reported as copies/mL for blood and copies/mg for tissue. Immunohistochemistry (IHC): Four-micrometer tissue sections were analyzed for CMV expression using the Ventana Benchmark XT platform. Nuclear staining was the primary indicator for CMV positivity, with known positive colon mucosa serving as the control. 4\. Statistical Analysis Data were analyzed using IBM SPSS Statistics Version 20.0. The normality of the data was verified using Shapiro-Wilk tests and visualization tools (histograms and Q-Q plots). Comparative Statistics: Categorical variables were assessed via Chi-square tests. Continuous variables were analyzed using Student's t-test (parametric) or the Mann-Whitney U test (non-parametric). Correlations: Relationships between viral loads and clinical variables were evaluated using Spearman's correlation and point-biserial correlation. A p-value of \<0.05 was maintained as the threshold of statistical significance.
NCT07384169
Procedures such as colonoscopy cause discomfort and pain and are therefore performed under sedation and analgesia. Although patients aged 65 and older frequently undergo colonoscopy procedures, it is unclear to what extent the anesthetic agents administered for sedation and analgesia in this patient group affect neurocognitive functions. Different sedation methods are used in colonoscopy procedures depending on the anesthesiologist's choice. Propofol is an agent frequently used in general anesthesia or for sedation during endoscopic procedures and, compared to inhaled agents, has more positive effects on postoperative cognitive functions. Dexmedetomidine is an alpha receptor agonist and is preferred due to its positive effects on cognitive functions in elderly patients, its lack of respiratory depression, its ability to provide sedation without impairing cooperation, and its analgesic effects. Although there are studies in the literature on the assessment of neurocognitive function in geriatric patients undergoing surgical procedures, the literature is insufficient in terms of studies addressing cognitive assessment after short-term, outpatient, and less invasive procedures such as colonoscopy. This study aimed to observe patients aged 65 years and older who underwent sedoanalgesia for colonoscopy and to compare the effects on cognitive function by administering the mini mental test before and after the procedure to this patient group.
NCT07367373
Patients scheduled to undergo elective colonoscopy will be evaluated in this observational study. No additional medications, interventions, or diagnostic procedures beyond standard clinical practice will be administered. The primary objective of the study is to investigate whether the quality of bowel preparation prior to colonoscopy varies according to seasonal differences. Bowel cleansing quality will be assessed during the colonoscopy procedure using standard evaluation criteria. The quality of bowel preparation will be compared across different seasons to determine the potential impact of seasonal variation on bowel cleansing adequacy prior to elective colonoscopy.
NCT07353853
The primary objectives of this project are twofold: firstly, to evaluate the role of Maifu Changqing® Complete Nutrition Formula Powder in bowel preparation for colonoscopy in patients with IBD; and secondly, to enhance the nutritional support and comfort of bowel preparation for IBD patients.
NCT07355777
Colonoscopy which is the standard examination for the exploration of the colon and rectum is performed very frequently. Colon preparation before the examination is an essential step and pescription of the colonic preparation is carried out by the gastroenterologist. However, despite a standardized explanation of the colon preparation, there is heterogeneity in understanding the colonic preparation, which in some cases compromises the quality of the colonoscopy examination. This clinical study aims to investigate whether an explanation of colonic preparation by tutorial films would increase the quality of colon preparation and would reach the recommendations of the Société française d'endoscopie digestive (SFED) in 2019.
NCT07328880
The goal of this randomized controlled trial is to compare the safety, compliance, and efficacy of different bowel preparation methods prior to colonoscopy. Researchers will compare 4-L split-dose polyethylene glycol and the bisacodyl + docusate sodium regimen versus 2-L split-dose polyethylene glycol plus oral simethicone regimen versus the conventional method for bowel preparation before colonoscopy. Participants will undergo history-taking, clinical examination, laboratory investigations, and colonoscopy. Patients will be randomly assigned to receive 4-L split-dose polyethylene glycol and bisacodyl + docusate sodium, a 2-L split-dose polyethylene glycol regimen plus oral simethicone, or 2-L split-dose polyethylene glycol alone as a control. Colonoscopy will be done 24 hrs after the start of medication. Researchers will assess the quality of the bowel preparation using the Aronchick bowel preparation scale. Researchers will also assess the number of adverse events and ask the patients about the ease of bowel preparation administration, tolerability of preparation regimen, and willingness to take the same agent again for a repeat colonoscopy in the future.
NCT07127354
The goal of this clinical trial is to learn how GLP-1 and GIP agonists effect bowel preparation in patients scheduled for colonoscopies. The main questions it aims to answer are: * Does GLP-1 and GIP agonist increase the rate of inadequate bowel preparation? * Does the quality of bowel preparation differ in patients who hold vs. those who continue a single dose of their GLP-1 or GIP agonist medication? * Are there any differences in the rates of complications gastric aspiration in patients who hold vs. continue a single dose of their GLP-1 or GIP agonist medication?
NCT07261059
Colorectal cancer (CRC) ranks the second most common cancer and the fourth leading cause of cancer-related deaths in China. Early screening of CRC has been proven to reduce the incidence and mortality, with colonoscopy as the gold standard for CRC screening. This trial aims to evaluate the effectiveness of artificial intelligence-assistant integrated care for improving uptake rate of colonoscopy among high-risk individuals aged 40 to 64 in China. It's a two-arm, parallel cluster randomized controlled trial. The main question it aims to answer is whether the AI-assisted integrated care influence participants' screening-related knowledge, health beliefs, behavioral intention, and uptake of colonoscopy. Participants will: 1. Be recruited and allocated into one of two groups according to the assigned clusters. Participants in one group will be invited to receive usual specialty care. In addition to usual specialty care, participants in the other group will receive AI-assisted integrated care provided by specialist and general practitioners collaboratively. 2. Complete a questionnaire survey on their knowledge, health beliefs, behavioral intention on CRC screening. 3. Have their colonoscopy status checked at the middle and end of trial.
NCT06635941
Colorectal cancer is one of the most common cancers globally and a leading cause of cancer-related death. Colonoscopy is the standard screening method for colorectal cancer, significantly reducing mortality rates. However, the pain experienced during the procedure is one of the main reasons people avoid getting a colonoscopy. If operators can identify patients who are more likely to feel pain before the procedure, operators can take steps to reduce their discomfort. Previous research has developed a model to predict discomfort during colonoscopy, but this model have some limitations in clinical use. Therefore, investigators plan to develop a new model that also predicts the likelihood of painful colonoscopies. This study aims to identify factors related to pain in non-sedated colonoscopy and create a more accurate prediction model to help reduce pain during the procedure. A total of 679 patients will be divided into two groups randomly for training and validation. Participants meet the inclusion criteria for this study, and investigators will ask participants to participate voluntarily. If participants agree, investigators will collect some of participants basic information and medical history, and assess participants' pain during the procedure. Participants will only need to follow the doctors' instructions, complete bowel investigators' preparation, and undergo the colonoscopy as usual. The data collection will not interfere with participants' regular care
NCT06688955
A joint opinion of the SFED and the SF2H recommends to orient our colonoscopy practices towards the use of bacteriologically controlled water in reusable bottles for colonic irrigation. To date, no study exists to validate the proposed set-up. Our main objective is therefore to evaluate the microbiological safety of the use of bacteriologically controlled water, in particular the absence of retro contamination of the water in the wash bottle by the faecal flora of the patient undergoing colonoscopy, in order to be able to generalise this practice
NCT07171853
With global warming intensifying, GI endoscopy is among the top three greenhouse gas-emitting medical procedures. Colonoscopy, a cornerstone for colorectal cancer (CRC) screening, significantly contributes to the carbon footprint (CF). This study quantifies CO₂ emissions in different steps of colonoscopy and evaluates the environmental impact of common polypectomy techniques to establish baseline CF data and identify opportunities for mitigation. This study included patients undergoing colonoscopy for CRC screening. CO₂ emissions were comprehensively measured at each step of the procedure (pre-, during, and post-colonoscopy), including energy consumption, all equipment and medications, waste management, and endoscopy reprocessing. Emission data were also collected for common polypectomy techniques, including cold forceps biopsy (CFB), cold snare polypectomy (CSP), hot snare polypectomy (HSP), and hot snare endoscopic mucosal resection (EMR), all performed according to standard polypectomy protocols.
NCT05088408
The high energy nutritional supplement Resource® Energy is approved for human nutritional support in various clinical conditions, yet it has been used off-label to alleviate the effects of hunger during bowel preparation for colonoscopy. Its impact in mucosa visualization quality and hunger alleviation is unknown. The product is liquid and nutritious but it is not transparent, thus it is conceivable that it could alleviate the discomfort of hunger during the preparation but possibly compromising mucosa visualization. In this study, participants who will undergo a colonoscopy (requested for an explicit medical indication) will take two bottles of the nutritional supplement during the usual bowel preparation. The quality of mucosal visualization and the participants opinion regarding satiety and product tolerance during bowel preparation will then be analysed.
NCT07165470
The primary objectives of this study are as follows: 1.To evaluate the efficacy of Maifu Changqing® Complete Nutritional Formula Powder in bowel preparation for colonoscopy among inflammatory bowel disease (IBD) patients;2.To enhance nutritional status and procedural comfort during bowel preparation in the IBD population.
NCT04474002
4L split dose PEG is the gold standard for bowel preparation, however it comes with poor tolerability and poor compliance. Combination of PEG with different agent is useful in reducing total volume, improving compliance and tolerance of patient. The objective of this study is to demonstrate that combination bowel preparation, PEG plus SPMC solution, has similar efficacy and safety profile whereas with a better tolerance when compared to large volume PEG.
NCT05220345
Colonoscopy is the gold standard for colorectal screening. The diagnostic accuracy of colonoscopy highly depends on the quality of inspection of the colon during the procedure. To increase detection new polyp detection systems based on artificial intelligence (AI) have been developed. However, these systems still depend on the ability of the endoscopist to adequately visualize the complete colonic mucosa, especially to detect smaller and more subtle lesions, or lesions hidden behind folds in the colon. With this study we want to combine a device to flatten the folds in the colon combined with an artificial intelligence system to further improve the detection rate of lesions during colonoscopy.
NCT06813703
This study is a single-center, randomized controlled trial aiming to evaluate the analgesic mechanism of Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture (TENS-WAA) during unsedated colonoscopy using EEG-fNIRS technology to assess neural activity in brain regions associated with pain perception. Sixty patients aged 18-75 years, with stable cardiopulmonary function and a baseline visual analog scale (VAS) pain score \<3, will be enrolled and randomly allocated into the intervention and control groups. The intervention group will receive TENS stimulation based on the Wrist-Ankle Acupuncture theory 10 minutes before the colonoscopy, with a frequency of 2 Hz and adjustable current intensity ranging from 1 to 9 mA. The control group will receive minimal-intensity sham stimulation under identical conditions. All participants will wear EEG-fNIRS devices to monitor neural activity in key pain-related brain areas, including the prefrontal cortex, anterior cingulate cortex, motor cortex, and parietal cortex. Primary outcomes include EEG-fNIRS data, while secondary outcomes are VAS scores at the four colonic bends, colonoscopy duration, and the correlation between EEG-fNIRS signals and pain perception. Statistical analyses will include multivariable linear regression, generalized estimating equations, and mixed-effects models to investigate the analgesic effects and neural mechanisms of TENS-WAA. This study seeks to provide innovative pain management strategies for patients undergoing unsedated colonoscopy and further explore the neuroregulatory potential of TENS-WAA technology.