Ileostomy

This research aims to evaluate the effectiveness of using a 3D scan to create personalized ostomy appliances for people with an ostomy. The study focuses on whether a 3D scan of the stoma can reduce leakages and improve quality of life compared to standard care. Ostomy appliances collect waste from the stoma but often cause complications such as skin irritation, leaks, and infections, which impact patients' daily lives. Participants will have their stoma scanned with a 3D scanner to create a detailed digital model. This model is then edited and used to produce a personalized ostomy appliance by modifying standard appliances with a laser cutter. The study involves two 2-week periods where participants use their usual ostomy appliance first, then the personalized 3D-printed appliance. The personalized appliances are designed with input from an ostomy nursing team to ensure proper fit based on each patient's body and stoma. During the 4-week study, participants will complete daily symptom diaries and weekly quality of life surveys conducted over the phone. Researchers will track leak incidents, the number of appliances used, and overall patient satisfaction. The study includes ongoing monitoring through electronic surveys requiring internet and device access. Total participation lasts about one month, with safety and quality of life as key measures.

Bladder cancer is a common type of cancer, especially in men, and most cases are non-muscle invasive at diagnosis. When it progresses to muscle-invasive bladder cancer, treatment usually involves chemotherapy followed by surgery called radical cystectomy with urinary diversion. Despite surgical advances, complications after this surgery remain frequent. The role and timing of ureteric stenting during this surgery to prevent urinary leakage and obstruction is uncertain, and prior studies have shown mixed results regarding its benefits and risks. This study is a randomized trial comparing early versus late removal of ureteral JJ stents after radical cystectomy and ileal conduit formation. Participants will be assigned to either have their stents removed early, between 5 and 7 days after surgery, or late, between 4 and 6 weeks after surgery. The study aims to assess the feasibility of conducting a larger definitive trial by evaluating complication rates and other outcomes related to the timing of stent removal. Participants will be monitored for complications within 30 days, 90 days, and up to one year after surgery. The study will also track readmission rates and feasibility outcomes over one year. Researchers will collect data on surgical complications and recovery, with no blinding involved. The total duration of participation varies, with follow-up visits to assess the effects of early versus late stent removal on patient outcomes.

Researchers are evaluating a new surgical method called Reduced-Port Fusion Surgery for patients undergoing temporary ileostomy during laparoscopic or robotic colorectal surgery. This study compares this new technique with traditional stoma positioning and surgery methods to see if it can reduce complications, lessen postoperative pain, improve quality of life, and make stoma retraction surgery easier. A total of 80 patients will be randomly assigned to either the new or traditional surgery group. The Reduced-Port Fusion Surgery involves preoperative planning where the stoma therapist and surgeon collaborate to create a joint trocar and stoma fusion point that allows more lateral stoma placement outside the rectus abdominis muscle. During surgery, the main trocar incision is extended to create the ileostomy at this fusion site, allowing dual use of one incision. The control group will receive traditional stoma positioning within the rectus abdominis and conventional ileostomy creation, ensuring the trocar and stoma sites do not overlap. Participants will be monitored for stoma-related complications, skin infection rates, hernia incidence, postoperative pain, and quality of life at 7, 30, and 90 days after surgery. Evaluations include the DET score assessing skin discoloration, erosion, and tissue overgrowth. The study also tracks infection rates at the stoma and trocar sites, parastomal hernia development, and pain levels. Quality of life is assessed at 30 and 90 days. The trial aims to provide detailed safety and effectiveness data over this follow-up period.

Short Bowel Syndrome (SBS) is a rare condition where a large part of the intestine is missing or has been removed, causing difficulty in absorbing enough food, water, and nutrients. This study focuses on children and teenagers with SBS who depend on parenteral support (PS) for more than 42 days to stay healthy. Researchers aim to learn how well teduglutide works to reduce the need for PS and to assess its safety in this group. The study includes three groups of participants: those who completed a 24-week teduglutide treatment before joining the study, those who started treatment before the study but have not finished 24 weeks, and those who will begin treatment after enrolling. Data will be collected retrospectively for earlier treatments and prospectively for ongoing or future treatments, covering up to 48 weeks for new starters. No intervention is administered by the study itself as it is observational. Participants will have their medical records reviewed, and new data collected during the study period. Researchers will measure changes in weekly PS volume, growth parameters, nutrition support, and safety through lab tests, vital signs, and adverse events. The main outcome is the percentage of participants achieving at least a 20% reduction in weekly PS volume at 24 weeks. The study will continue until September 2027, with ongoing monitoring of health and treatment responses.

Researchers are studying the use of a stoma self-care app accessed through the LINE official account, a communication platform popular among Chinese users, to help patients with enterostomy. The study aims to explore how technology acceptance and task technology fit impact patients' self-care ability and quality of life. Enterostomy patients often face challenges in self-care that can lead to complications, affecting their physical and emotional well-being as well as their families. The study compares two groups: one using the stoma self-care app as an intervention and a control group receiving traditional education with a health manual and oral instructions. This is a randomized, single-blind, quasi-experimental study involving patients after colostomy surgery. The intervention starts on the first day after surgery and integrates models to assess and improve self-care knowledge, ability, and quality of life. Participants will be evaluated using scales for enterostomy self-care knowledge, self-care ability, and quality of life from day 1 to day 28 after surgery. Questionnaires will assess task technology fit and usage behavior. The study monitors how well patients adapt to stoma care and measures their quality of life during this period to understand the impact of the app compared to conventional education.

Researchers are conducting a survey to understand how well participants and physicians know how to use GATTEX, a treatment for Short Bowel Syndrome (SBS), and to identify potential risks. This survey is part of a safety program called the Risk Evaluation and Mitigation Strategy (REMS), required by the US FDA to ensure certain medicines with serious risks are used safely. The main goal is to assess knowledge about the necessary checkups and tests while using GATTEX and the possible risks involved. The survey is non-interventional and participants include those who have taken GATTEX within 60 days before the survey and healthcare providers in the US who have prescribed GATTEX at least once. The survey can be completed online, by telephone, or on paper, based on the participant's preference. No study medicines are provided during this research. Participants will answer questions to measure their understanding of GATTEX safety and use. Researchers will count how many provide correct answers and how well they understand the knowledge areas of the survey. This assessment occurs every two years as part of ongoing safety monitoring. The survey aims to help improve safe use of GATTEX over time.

Researchers are evaluating whether postoperative antibiotics targeted to bacteria found in urine can reduce infections after bladder removal surgery (cystectomy) compared to a standard antibiotic approach. This trial focuses on patients undergoing cystectomy, a surgery with a high risk of infection and readmission within 90 days. The study aims to improve recovery by testing a more personalized antibiotic strategy against the current standard treatment. Participants will be randomly assigned to one of two groups after surgery: one group will receive a standard antibiotic called pivmecillinam taken three times on the day of ureteral stent removal, while the other group will receive a single-day targeted antibiotic based on bacteria detected in a postoperative urine sample. If no bacteria are found, no antibiotics will be given. All other care before, during, and after surgery will follow usual hospital guidelines. During the 90-day follow-up, participants will provide urine samples and complete quality of life questionnaires before and after surgery. Researchers will collect data on infection-related hospital readmissions, complications, and antibiotic use from medical records. The main goal is to see if the targeted antibiotic reduces infections leading to readmission within 90 days. The study includes detailed monitoring and plans for early analysis to ensure participant safety and study effectiveness.

This research aims to explore the effects of GLP-1 receptor agonists on intestinal barrier function in patients with short bowel syndrome and intestinal failure (SBS-IF). Participants are adults aged 18 to 80 years with confirmed SBS-IF receiving parenteral nutrition due to surgical resection of the small intestine. The study compares a group receiving semaglutide, a GLP-1 analog, alongside standard care to a control group receiving placebo plus standard care. The trial is randomized and single-blinded to assess treatment impact. Participants in the GLP-1 group receive subcutaneous injections of semaglutide at a dose of 0.25 mg once weekly for 28 days, following the manufacturer's instructions. The control group receives an appearance-matched placebo alongside standard care without additional GLP-1 intervention. The treatment period is strictly 28 days, with outcomes measured before and after this treatment phase. Throughout the study, participants undergo assessments including serum biomarkers of intestinal barrier function, nutrient absorption (protein, carbohydrate, fat), nutritional status indicators, parenteral nutrition liberation rate, and quality of life scores. These measures are collected at enrollment and after completing the 28-day treatment. The trial monitors participant health and adherence closely, aiming to evaluate the therapeutic effects of GLP-1 on intestinal health in this population.

This observational study focuses on parastomal hernia repair using endoscopic methods. It evaluates laparoscopic and robotic extraperitoneal mesh repair techniques that include transversus abdominis release (TAR) and mesh reinforcement following the Sugarbaker principle. The study aims to assess these surgical approaches and their outcomes over time. The repair involves an endoscopic trans-abdominal preperitoneal plasty (TAPP) method placing mesh extraabdominally, anterior to the transversalis fascia. Both laparoscopic and robotic procedures are used, with additional repair of any midline hernias through an enhanced-view Rives-Stoppa technique. This approach is studied for safety and effectiveness in reinforcing hernia repair. Participants will be monitored for adverse events within one month after the procedure, with further follow-up over two years to observe late complications and hernia recurrence. The study collects data through clinical evaluations during this period. Participation duration varies with follow-up assessments scheduled up to two years after surgery to ensure comprehensive monitoring of outcomes.

Researchers are studying how drugs are absorbed in patients with ostomies, focusing on psychotropic drugs and novel oral anticoagulants (NOACs). These drugs' absorption is not well understood in ostomy patients, as previous studies often involve only small groups or case reports. The study aims to find out if therapeutic blood levels are reached when these medications are taken orally by ileostomy and colostomy patients. This observational trial monitors drug levels by collecting blood samples during routine medical care, avoiding additional risks to participants. The study compares measured drug levels in ileostomy and colostomy patients to the therapeutic ranges defined in previous approval studies. Relevant patient data and plasma drug levels will be recorded and analyzed to evaluate absorption. Participants will be patients with an ileostomy or colostomy who have been taking specified psychotropic drugs or NOACs for at least seven days. Blood samples taken as part of regular treatment will be used to measure drug levels. The main outcome is whether therapeutic serum concentrations are achieved over an 18-month period. The study is sponsored by WiGeV Klinik Ottakring and involves no extra risks beyond routine care.