Cholecystitis (Gallbladder Inflammation)

Researchers are evaluating the effectiveness of low volume Transanal Irrigation (TAI) using the Qufora IrriSedo MiniGo device combined with standard conservative treatments compared to conservative treatment alone for patients with Low Anterior Resection Syndrome (LARS). This condition affects individuals who have undergone surgery for rectal cancer. The study aims to assess improvements in clinical symptoms of LARS over a three-month period. Participants are divided into two groups: one receiving low volume TAI with the MiniGo device plus standard conservative care, which includes dietary management, counseling, and prescribed medications excluding suppositories and physiotherapy; and another group receiving only the standard conservative treatments. The study includes follow-ups at 6 weeks, 3 months, and up to 12 months to monitor various outcomes. During the study, participants will be regularly assessed using the LARS score to measure symptom changes, quality of life questionnaires (EORTC QLQ-C30 and QLQ-CR29), incontinence scores, patient satisfaction, treatment compliance, bowel management time, and healthcare resource usage. Data will be collected at multiple intervals including 6 weeks, 3 months, 6 months, 9 months, and 12 months to thoroughly evaluate the treatment impact and patient preferences.

Trauma is a leading cause of death in children in the US, with abdominal trauma accounting for 30% of pediatric traumatic deaths, second only to brain injury. This research evaluates the use of the Focused Assessment with Sonography for Trauma (FAST) examination, a bedside abdominal ultrasound, to determine if it can safely reduce abdominal CT scans in hemodynamically stable children with blunt abdominal trauma. The study aims to improve care quality and reduce morbidity and mortality by identifying appropriate evaluation strategies for injured children. The trial is a multicenter, randomized, controlled study involving 3,194 children under 18 years presenting within 24 hours of blunt abdominal trauma. Participants are assigned to either the FAST examination arm, where a bedside ultrasound is performed to detect blood in the abdomen, or to the standard care arm without FAST. The FAST exam is quick, radiation-free, and performed by emergency or trauma physicians. The study compares CT scan rates and tracks delayed or missed diagnoses of intra-abdominal injuries over up to 30 days. Throughout the emergency department stay and initial hospitalization (up to 24 hours), participants undergo assessments including FAST or standard evaluation, CT scan monitoring, and tracking of injuries for up to 30 days if hospitalized. Outcomes measured include CT scan frequency, missed injuries, emergency department length of stay, hospitalization rates, physician suspicion of injury, and surgery rates. The study also examines factors influencing CT use in low-risk patients after a negative FAST exam, aiming to optimize diagnostic care in pediatric trauma.

Gallstones are a common health issue, and their occurrence has been increasing worldwide. This research aims to evaluate whether dietary therapy can help in expelling early-stage gallstones, specifically those present in a sludge-like form, which currently lack effective treatment options. The trial is a double-blind, prospective study conducted at a single medical center to investigate this question. Participants are randomly assigned to receive either functional fatty acids or a placebo orally. The treatment period lasts six days, with the experimental group taking functional fatty acids throughout. The placebo group receives placebo for the first three days, followed by functional fatty acids for the next three days. This design allows comparison of gallstone expulsion effectiveness between the groups. During the study, participants will undergo assessments including sonographic evaluation of gallbladder sludge expulsion after three and six days, as well as measurements of gallbladder volume and wall thickness. Researchers will also monitor blood bilirubin levels and observe any post-intervention symptoms such as abdominal pain, acute pancreatitis, gastrointestinal bleeding, nausea, vomiting, and diarrhea. The study period and follow-up span up to two weeks, ensuring thorough safety and outcome monitoring.

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.

Researchers are studying nutritional support strategies for critically ill patients with impaired gastrointestinal function, focusing on how to best achieve energy and protein intake goals. The study investigates the use of enteral nutrition alone versus a combination of enteral nutrition and supplemental parenteral nutrition (SPN) in patients who have impaired gastric emptying and reduced intestinal absorption. This research addresses the challenge of feeding intolerance and malnutrition in intensive care patients and explores muscle mass and function as important factors in nutrition efficacy. The study randomly assigns patients with diagnosed gastrointestinal dysfunction to one of two groups: one receiving gradual increases in enteral nutrition based on tolerance, and the other receiving a mix of enteral trophic feeding plus SPN to meet nutritional targets. Nutritional needs are monitored daily by indirect calorimetry, and gastrointestinal function is assessed with ultrasound gastric residual volume and a paracetamol absorption test. The SPN group aims to reach 80% of nutritional goals by day five, while the enteral nutrition group aims for full caloric intake as tolerated. Participants are monitored through various evaluations including muscle thickness via ultrasound, lean body mass by bioelectrical impedance analysis, and muscle strength with a handgrip dynamometer at admission and on days 10 and 15. The study measures daily calorie and protein intake adequacy, metabolic markers, and clinical outcomes such as mortality up to 28 days. Nutritional status, muscle function, and energy utilization are carefully assessed throughout the study to understand the impact of the tailored feeding protocols.

This research aims to understand who teaches gastrointestinal (GI) surgical procedures to senior general surgery residents during their training and to assess the residents' comfort level with performing both common and complex GI procedures. It also seeks to explore the need and interest for an Advanced Surgical GI fellowship among these senior residents. The study is observational and focuses on fourth and fifth year general surgery residents in accredited programs in the United States. The study involves an anonymous survey to collect information about the training sources for advanced GI surgical procedures and how confident senior surgical residents feel in performing these procedures after residency. There are no experimental treatments; instead, the survey gathers data regarding training experiences and residents' self-reported competence. The survey aims to provide insights into residency training and fellowship interest over a one-year period. Participants will complete the anonymous survey, sharing their experiences and comfort levels with GI surgery training. Researchers will analyze this information to better understand training adequacy and fellowship needs. The primary outcome measure is the training of senior general surgical residents over one year. No medical procedures or interventions are performed as part of this study, and participation involves only survey completion.

Researchers are evaluating how artificial intelligence (AI) can improve safety during laparoscopic cholecystectomy, a minimally invasive gallbladder removal surgery. This study compares surgeries guided by AI tools to standard procedures without AI, focusing on whether AI helps surgeons achieve the Critical View of Safety, a key step to reduce the risk of serious complications. This randomized controlled trial includes surgeons or fellows performing the procedures and aims to collect feedback on AI use and surgical safety outcomes. The study involves 10 surgeons or fellows and 50 adult patients undergoing laparoscopic cholecystectomy at two hospital sites. Participants are randomly assigned to either the control group using standard surgical care or the intervention group where surgeons receive real-time guidance from two AI models displayed on a monitor during surgery. The AI models highlight safe and unsafe dissection zones and provide text feedback on achieving surgical safety milestones. Surgeons can toggle or turn off AI guidance as needed. Procedures are recorded for post-operative review by expert surgeons. During the study, researchers will collect internal laparoscopic recordings, surgeon feedback immediately after surgery, observational notes during procedures, and review patient charts up to 30 days post-operation. The primary outcome is the rate at which surgeons achieve the Critical View of Safety, monitored for up to one year after surgery. Secondary outcomes include the safety of dissections, surgeon experience with AI, and short-term patient outcomes. The study lasts from surgery through one year of follow-up for outcome analysis.

Researchers are developing and managing the AnovaOS Network Powered Patient Registry to collect real-world patient data across various diseases globally. This registry aims to capture meaningful clinical information on diagnosis, infection course, treatments, and outcomes to enhance understanding and support future clinical trials and observational studies. The registry serves as a resource to better understand, prevent, diagnose, and treat diverse health conditions. Participants' data will be gathered through this registry, which can also be used to recruit individuals for clinical trials and observational studies on promising therapies. The registry collects ongoing information on patients' health status and treatments, enabling long-term monitoring and analysis. This observational study does not involve administering treatments but focuses on data collection and management. Participants will provide information through questionnaires or instruments, either personally or via an informed proxy, with an expected follow-up once per year. The research team will assess natural history, clinical effectiveness, safety, and quality of care over a period of five years. The registry includes patients with a wide range of conditions, and participation requires informed consent and the ability to complete follow-up data collection.

This clinical trial is studying elderly patients aged 65 and above undergoing painless gastroscopy and colonoscopy to evaluate the use of remimazolam combined with esketamine as an opioid-free anesthesia (OFA) protocol. Researchers aim to determine if this new protocol is feasible and not inferior to the traditional opioid-containing anesthesia (OA) protocol using remimazolam combined with remifentanil. The study focuses on comparing sedation success and safety between these two anesthesia methods in elderly patients with gastrointestinal disease. Participants are randomly assigned to one of two groups: one group receives anesthesia with remimazolam combined with esketamine, while the other group receives remimazolam combined with remifentanil. Both groups receive initial doses adjusted by body weight during anesthesia induction, with additional doses given during the procedure according to sedation depth and patient movement. The protocol includes drugs such as lidocaine and changtonine alongside the main anesthetics. During the study, researchers will monitor respiratory and circulatory indicators, including oxygen saturation, respiratory rate, heart rate, blood pressure, and sedation levels from the start of anesthesia induction until the end of surgery. They will also record adverse events, recovery times, patient and doctor satisfaction, and cognitive assessments before and after the procedure. Follow-up assessments include telephone interviews and confusion evaluations up to seven days post-surgery to ensure safety and recovery. The trial is planned to continue until January 2028.

Researchers are studying how fluctuations in anesthesia depth during surgery, measured by bispectral index (BIS) monitoring, affect patients' recovery quality after surgery. This observational study focuses on adults undergoing elective laparoscopic gallbladder removal under general anesthesia. The goal is to understand the relationship between BIS variability during anesthesia and changes in recovery quality as measured by a specific questionnaire. All participants will receive standard general anesthesia care with BIS monitoring as part of routine practice. BIS values will be recorded throughout the surgery without altering usual anesthesia management. Recovery quality will be assessed before surgery and again on the first day after surgery using the Quality of Recovery-15 (QoR-15) questionnaire. Additional data like delirium screening and perioperative clinical information will also be collected. Participants will complete the QoR-15 questionnaire before surgery and on postoperative day one. Researchers will collect BIS data continuously during the procedure and record other clinical information. The main measure is the change in QoR-15 score from before surgery to the first postoperative day. Additional outcomes include postoperative delirium and pain intensity. The study does not involve interventions beyond routine care and aims to improve understanding of how anesthesia stability impacts recovery.