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 patients 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 evaluating the safety, tolerability, and effectiveness of apraglutide compared with a placebo in adults with short bowel syndrome associated with intestinal failure SBS-IF. This Phase 3, double-blind, randomized, placebo-controlled study aims to include about 124 adult participants who rely on parenteral support PS at least three days per week. Participants are stratified by anatomy and baseline PS volume to ensure balanced study groups. Participants will be randomly assigned to receive either weekly subcutaneous injections of apraglutide or placebo for 24 weeks. The study consists of four periods Screening including optimization and stabilization, Treatment, Safety Follow-up after the last dose, and an Anti-Drug Antibody Follow-up period. Those completing treatment may join a long-term extension study with apraglutide or complete a safety follow-up visit before entering the antibody monitoring phase. During the study, participants will have their weekly parenteral support volume measured to assess changes. Additional assessments include reductions in PS days per week, achievement of enteral autonomy, and patient-reported global impression of change. Safety will be monitored through adverse event tracking and laboratory tests. Participants are expected to adhere to fluid intake monitoring and may undergo colonoscopy or imaging to remove any polyps. The entire participation timeline extends beyond treatment to ensure thorough safety and immune response evaluation.

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 participants 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.

Ulcerative colitis UC is a condition causing long-term inflammation in the digestive tract, often leading to surgery that creates a J-pouch for stool. Some people with this pouch develop pouchitis, an inflammation problem with limited treatment options and no known prevention methods. This phase 2 study evaluates whether a natural mineral supplement called Aquamin4 can reduce inflammation and protect the gut lining in people with a UC J-pouch, potentially lowering the risk of pouchitis. Participants will be randomly assigned to take either Aquamin4 or a placebo for one year. Aquamin4 is given orally as 2400 milligrams daily about 800 milligrams calcium in capsules taken twice or all at once. If swallowing capsules is difficult, they can be opened and mixed with liquid or soft food. Participants will also take lactulose and mannitol at the start, middle, and end of the study to measure gut permeability. During the study, participants will be monitored for the time to onset of pouchitis symptoms using a clinical index. Researchers will assess intestinal permeability, inflammation markers like serum C-reactive protein and fecal calprotectin at baseline, 6 months, and 12 months. The study includes safety monitoring and aims to understand how Aquamin4 may impact gut health and inflammation over the one-year treatment period.

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.

Researchers are comparing two surgical techniques used during colostomy surgery to evaluate their effect on the development of parastomal hernia PSH, a common and painful complication where a hernia forms around the stoma. PSH can significantly affect quality of life and may require additional surgery. The study aims to provide high-quality evidence on whether mesenteric molding suturing, which shapes and supports the tissue around the stoma, reduces PSH incidence compared to the traditional non-molding suturing technique. Participants will be randomly assigned to one of two groups. One group will undergo colostomy surgery using the conventional non-molding suturing technique without shaping the mesentery. The other group will receive mesenteric molding suturing, where the mesentery around the stoma is shaped and sutured to strengthen support and potentially lower hernia risk. Both procedures involve selecting a stoma site within the rectus abdominis muscle and forming the stoma with a tight fit of surrounding tissues. During the study, participants will be monitored for one year after surgery to assess the incidence of parastomal hernia and other stoma-related complications. Researchers will also measure operative time, recovery of stoma function, and quality of life. Follow-ups and assessments will help determine the comparative benefits of each technique and guide future surgical practices for colostomy patients.