Diverticulitis

The GENESIS clinical study aims to map HLA genetic variation in the Greek population and evaluate possible correlations with selected underlying diseases. It is a multicenter, prospective, non-interventional clinical study targeting 12,000 subjects over an anticipated duration of 36 months, with the goal of creating a pilot HLA map for medical research and possible clinical applications. Each subject will complete one visit at a participating site and provide demographic information, including date of birth, gender, race, ancestry, height, and weight, as well as information about smoking or vaping, alcohol consumption, arterial blood pressure, diagnosed diseases, and current treatments. Recent clinical laboratory results from up to 12 months before sample collection may also be collected when available, including blood count, metabolic, liver enzyme, and biochemical parameters. Two buccal swabs will be collected from each subject for DNA extraction and HLA genotyping analysis. Selected DNA samples will also undergo low-pass whole genome sequencing to further investigate associations between the HLA region and autoimmune diseases. After the analysis is completed, an individualized ancestry report will be securely available to study subjects if they elect to access it.

Frailty is a common condition in older adults that can increase the risk of poor health outcomes such as falls, hospital stays, and death. This research aims to study how assessing frailty before a colonoscopy might affect patient satisfaction and the number of colonoscopies avoided. The study is a prospective randomized controlled trial involving patients over 65 years old at Princess Alexandra Hospital, comparing a personalized approach using a frailty assessment to standard care. Participants will be randomly assigned to one of two groups. One group will receive a personalized approach that includes a frailty assessment using tests like grip strength, sit-to-stand timing, balance, and gait speed, along with questionnaires about medical conditions. The gastroenterologist will discuss the results and risks with the patient to help decide about having a surveillance colonoscopy. The other group will receive standard care, which involves discussing the benefits and risks of colonoscopy without the frailty assessment. During the study, participants will complete satisfaction questionnaires at the time of consultation and within weeks after any colonoscopy procedure. Researchers will track how many patients choose to avoid colonoscopy after receiving information and will monitor colorectal cancer-related complications and other causes of death within five years. The study will assess how the personalized approach may impact decision-making and patient satisfaction with outpatient services related to colonoscopy care.

Researchers are evaluating a combined screening and follow-up management approach for gastrointestinal tumors. This study aims to explore and assess the feasibility and cost-effectiveness of screening for esophagus, stomach, and colorectal cancers in a population-based, multicenter setting. The trial includes participants aged 45 to 70 years and will observe outcomes over a 10-year follow-up period. Participants are divided into groups undergoing different screening methods. Group one receives gastroscopy, colonoscopy, fecal occult blood test FIT, Helicobacter pylori antigen test, RNF180 and SEPTIN9 gene methylation tests, along with an investigation of various risk factors such as past diseases, lifestyle habits, family cancer history, and reproductive status. Group two undergoes risk factor investigation, FIT, and Helicobacter pylori antigen stool test if positive, further gene methylation tests and possibly colonoscopy are conducted. Control groups matched by spouse or sibling undergo only risk factor investigations. During the study, participants provide information on medical history, lifestyle habits, and family cancer history. Screening tests including endoscopies, stool tests, and gene methylation analyses are performed as specified. Researchers will monitor the detection of cancer or precancerous lesions over 10 years, tracking health outcomes and the effectiveness of combined screening. Safety and adherence are observed throughout the follow-up.

Researchers are evaluating the effectiveness and cost-efficiency of early remote interventions for patients with severe, chronic, or relapsing gastrointestinal symptoms that lack clear explanation and who are waiting for care in an integrated clinic. The study uses a two-stage randomization to compare different approaches, aiming to improve symptom management, identify which patients respond best to certain treatments, and assess acceptance of new care models. About 200 patients will initially have their symptoms and wheat intolerance assessed remotely. Participants who continue to experience symptoms after initial assessment will be randomly assigned to one of four pre-consultation interventions a standardized dietician-supervised program, an exercise program, internet-delivered cognitive behavior therapy, or no intervention. Following this, they will be randomized again to receive either a consultant-led outpatient clinic consultation or care in an integrated clinic, depending on their response to the pre-consultation intervention. Throughout the study, participants will be regularly assessed using a structured gastrointestinal symptoms score and quality of life measures, collected at multiple time points up to 44 weeks. Additional evaluations include anxiety and depression scales, microbiome analysis, and acceptance of care models by patients and staff. Cost-effectiveness will also be tracked. The total participation involves remote interventions, clinical consultations, and multiple assessments over time to monitor symptoms, quality of life, and treatment impact.

Researchers are investigating whether circulating tumor DNA ctDNA testing can help guide chemotherapy before surgery in patients with colorectal or appendiceal adenocarcinoma who have metastatic peritoneal disease. The study aims to determine if ctDNA levels can classify patients as low or high risk for cancer recurrence and assist doctors in deciding the intensity of chemotherapy needed before cytoreductive surgery CRS with or without heated intraperitoneal chemotherapy HIPEC. Participants will have their ctDNA levels measured at the start and during neoadjuvant chemotherapy. This information will be used to tailor the duration of chemotherapy given intravenously before surgery. The study focuses on patients undergoing CRS and HIPEC with curative intent, comparing outcomes based on ctDNA status before treatment. During the trial, patients will undergo blood tests to measure ctDNA and various assessments to monitor treatment response and safety. Researchers will track recurrence-free survival, overall survival, and adverse events over about one year. Additional evaluations include tumor biology, imaging characteristics, and changes in chemotherapy regimens based on ctDNA results. Participation involves ongoing monitoring before and after surgery to understand the impact of ctDNA-guided therapy.

Researchers are evaluating the impact of regular use of a consumer-grade FODMAP-targeting digestive enzyme blend called FODZYME on gastrointestinal symptoms in adults who experience self-reported bloating. The study focuses on how this enzyme blend affects symptoms such as bloating and abdominal pain, which are often triggered by fermentable carbohydrates known as FODMAPs. This is a randomized, double-blind, placebo-controlled crossover trial that aims to provide a more flexible alternative to the restrictive Low FODMAP Diet by breaking down FODMAPs before they ferment in the colon. Participants will take the enzyme blend or a placebo with each meal, snack, or substantial beverage, applying it directly to their food. The trial is divided into two main periods half the participants will start with the enzyme blend for four weeks followed by a two-week washout and then switch to placebo for another four weeks the other half start with placebo and then switch to the enzyme blend after the washout. The study product is designed to target specific FODMAPs like fructan, GOS, and lactose and is intended for adults with or without IBS symptoms. During the study, participants will complete daily questionnaires and assessments over about 19 weeks, including patient-reported outcome measures for bloating, gastrointestinal symptoms, abdominal pain, food-related quality of life, and anxiety. The study is conducted remotely, allowing participants to complete assessments at home using a smartphone app. Safety is monitored by excluding those with known allergies to corn or previous reactions to digestive enzyme supplements, and researchers will review changes in bloating symptoms as the primary outcome.

This observational study aims to understand how force feedback instruments are useful during surgeries performed with the da Vinci 5 robotic system. It focuses on procedures such as inguinal and ventral hernia repairs, colorectal, thoracic, gynecologic surgeries, and partial nephrectomy. The study is designed to gather information on how these instruments perform during robotic-assisted surgery. Participants will undergo multi-port robotic-assisted surgery using the da Vinci 5 system equipped with force feedback instruments, which provide tactile sensations. The study observes surgeries planned as primary procedures with these instruments, without altering the treatment. There is no experimental drug or placebo involved, as this is an observational study conducted after the devices have been marketed. During the study, researchers will measure the force applied to tissues by the force feedback instruments during surgery and evaluate how useful these instruments are during specific steps of the procedure before patient discharge. Participants will be followed up as per the study protocol to ensure data quality. The total participation time varies depending on the surgical procedure and follow-up schedule.

Researchers are comparing two bowel cleansing agents, Plenvu and Picoprep, used before colonoscopy to check for colon disease, mainly to exclude cancer. This phase 4 trial investigates whether the newer, low-volume Plenvu is at least as effective as the established Picoprep in cleaning the bowel, while also examining patient tolerability and compliance. The study is conducted at a single center in North Jutland with 400 patients referred for colonoscopy. Participants are randomly assigned to receive either Picoprep or Plenvu. Picoprep involves taking two doses dissolved in water before the procedure, with fluid intake totaling approximately 2.3 liters. Plenvu is taken in a two-day regimen with two separate doses dissolved in 500 ml water each, accompanied by additional fluids for a total of 2 liters. Both agents require dietary restrictions before colonoscopy, including avoiding seed-containing foods five days prior and following a fluid diet the day before. During the study, participants complete a questionnaire about side effects and their experience with the bowel preparation before the colonoscopy. The colonoscopist, who does not know which agent was used, assesses bowel cleansing quality using the Harefield Cleansing Scale. Data on efficacy and tolerability are collected and analyzed. Participants are followed for about 30 hours after the last dose. The trial will end once 400 patients have completed participation.

This research aims to reduce surgical disparities experienced by patients with low health literacy, a group at higher risk for complications, longer hospital stays, and readmissions after surgery. The study focuses on adapting enhanced recovery programs ERPs, which have shown promise in reducing racial disparities but currently do not fully meet the needs of low health literacy patients. The project plans to test a new implementation strategy called VISACT, designed to improve ERP delivery and outcomes for this vulnerable population. The VISACT intervention combines visual aids, coaching for providers on communication, and training for organizations in health literacy. This multilevel strategy will be delivered through an interactive response platform to patients, healthcare providers, and organizations. The pilot trial will take place over 2.5 years at two sites, including baseline data collection for 6 to 12 months, a one-month intervention delivery period, and 18 to 24 months of post-intervention data collection to assess its impact. Participants will include adult patients undergoing surgery with ERPs, as well as caregivers, providers, and organizational leaders involved in ERP implementation. The study will assess the reach, efficacy, adoption, implementation fidelity, and maintenance of the VISACT intervention using various measures such as length of hospital stay, readmission rates, and complication rates. Data collection will occur throughout the study, with the primary outcome focused on the interventions reach to patients and providers over 16 to 24 months. The total study duration extends until May 2028.

Researchers are evaluating the Stream Platform, which includes the Origin inline biosensor system, for accurately monitoring the pH of abdominal drainage fluid in patients after gastrointestinal surgery. This study aims to validate the analytical performance of the Origin device, including its precision, linearity, specificity, and how well it compares to standard laboratory methods. The study involves patients who have undergone colorectal, hepatobiliary, trauma, or acute care surgeries and have abdominal drains in place. The study collects abdominal drainage fluid samples daily from patients until their hospital discharge or drain removal, as determined by their surgeon. These samples, along with commercially available calibration fluids and simulated peritoneal fluids, will be used to test and verify the accuracy and reliability of the pH measurements by the Origin system. The study also includes evaluation of novel features of the Origin device designed to improve user workflow. Participants will have samples collected daily without any additional risk, as the fluid is normally discarded after surgery. No personal health information is collected, and no follow-up is required after discharge or drain removal. The research team will assess the devices measurement traits over an 8-month period, including testing for precision, linearity, specificity, and method comparisons. The total participation lasts until the patient is discharged or the drain is removed.