Cholelithiasis (Gallstone)

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.

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 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 studying patients with suspected choledocholithiasis, a condition involving gallstones in the bile duct, who fall into an intermediate likelihood group based on current risk criteria. The study aims to evaluate how a machine learning model can help predict choledocholithiasis and potentially reduce the need for additional diagnostic procedures like Endoscopic Ultrasound (EUS) or Magnetic Resonance Cholangiopancreatography (MRCP). This approach may lower healthcare use and costs for these patients. This observational study uses a machine learning-based predictive model to stratify patients who otherwise might undergo EUS or MRCP. Participants are those aged 18 to 80 years with intermediate risk of choledocholithiasis. The model's performance in predicting the condition will be assessed, focusing on accuracy and receiver operating characteristic curve analysis within one month. Participants will be monitored through diagnostic evaluations including EUS or MRCP as needed, with data collected to validate the machine learning model. Researchers will measure the model's accuracy and compare it to the diagnostic tests. The study will track outcomes over one month, assessing how well the model predicts the presence of choledocholithiasis and its potential to reduce unnecessary diagnostic procedures.

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.

The Calgary Registry for Advanced and Therapeutic Endoscopy (CReATE) is a high-quality, prospective study collecting data on adult patients undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) for biliary and pancreatic diseases. The registry aims to gather detailed information from multiple centers to better understand outcomes and complications related to this advanced endoscopic procedure. Participants undergo ERCP, an endoscopic procedure used to access biliary and pancreatic structures. The study observes patients consecutively from September 2018 to August 2022, capturing all relevant data before, during, and after the procedure. This includes procedural details and patient outcomes, serving also as a platform for additional prospective studies and randomized trials. During the study, a full-time research assistant collects real-time data by observing procedures directly. Participants are followed up with medical record reviews and phone interviews 30 days after the procedure to assess outcomes such as unplanned healthcare visits and procedure-related complications including pancreatitis, bleeding, and infections. The registry monitors technical success immediately and tracks patients' health for up to 30 days post-procedure, contributing to ongoing research until the study ends in 2030.

Researchers are evaluating the risks and benefits of performing intraoperative cholangiography (IOC) routinely versus selectively during gallstone surgery in patients without suspicion of common bile duct stones (CBDS). This national multicenter randomized controlled trial aims to provide clearer evidence on whether routine IOC reduces complications such as pancreatitis, obstructive jaundice, or cholangitis compared to selective IOC, which is performed only when bile duct anatomy is unclear during surgery. The study addresses an important knowledge gap in gallstone surgery practices internationally. Participants will be randomly assigned to one of two groups: routine IOC, where the procedure is attempted regardless of indication or anatomy, or selective IOC, where it is done only if there is uncertainty about the bile duct anatomy. The trial is embedded in the Swedish Registry for Gallstone Surgery and will include about 6,000 patients undergoing laparoscopic cholecystectomy. Patients with preoperative suspicion of CBDS or other related conditions are excluded. The study will follow participants for 12 months after surgery to monitor for complications. During the study, patients will be monitored for readmissions or need for reinterventions related to the surgery within one year. Data collected will include procedure time, mortality rates, hospital stay length, and patient quality of life measured by standard questionnaires at baseline, 30 days, six months, and one year after surgery. The trial uses registry data and routine follow-up visits to track outcomes, aiming to evaluate the overall morbidity related to the different IOC approaches.

This research aims to compare the safety and effectiveness of laparoscopic cholecystectomy versus a wait-and-see approach in elderly patients who have had common bile duct stones successfully removed using endoscopy. The study focuses on patients 75 years and older, including those with additional health issues, to determine if avoiding surgery is as safe as performing cholecystectomy. The main measurement is a combined outcome of death, serious complications, or recurring biliary problems within one year after randomization. Participants are randomly assigned to one of two groups: one will have laparoscopic cholecystectomy within two weeks following stone removal, and the other will be managed without surgery but can have cholecystectomy later if needed. The study includes an interim safety check after the first 100 participants, with a plan to stop early if significant differences arise. Both groups are monitored over time to assess health outcomes and complications. During the study, participants will be followed for at least one year to track outcomes such as survival, complications, biliary events, quality of life, pain, and healthcare costs. Assessments occur at various intervals, including 30, 180, and 365 days after randomization. Researchers will evaluate these factors carefully to understand the benefits and risks of each approach, ensuring participant safety throughout the trial.

Gallstone disease is common in China, affecting about 15% of the population, with 210 million people affected. Acute cholecystitis, a sudden inflammation of the gallbladder often caused by gallstones, can lead to serious complications such as gallbladder perforation and high mortality if untreated. This study investigates the effects of single-incision laparoscopic cholecystectomy (SILC) compared to conventional laparoscopic cholecystectomy (CLC) on patient outcomes after surgery for acute cholecystitis, aiming to improve quality of life and reduce pain and scarring. The trial compares two surgical methods: SILC, which uses a single incision through the navel, and CLC, which involves three or four small incisions. Both groups may switch to open cholecystectomy if the surgery is difficult to complete. The study is randomized and triple-blinded to ensure unbiased results. Researchers want to establish a standardized procedure for SILC in treating acute cholecystitis and evaluate its safety and impact on postoperative recovery. Participants will be followed for three years to assess the time it takes to return to normal life, the cosmetic results of surgery, postoperative pain, scar quality, and any complications. The study includes regular monitoring and evaluation to measure these outcomes and ensure participant safety. This long-term follow-up will provide valuable information on the effectiveness and patient experience with SILC compared to traditional laparoscopic surgery.

Cholelithiasis affects 10-20% of the general population, with up to 18% experiencing symptoms such as acute cholangitis, obstructive jaundice, or biliary colic. This trial investigates whether adding transmural gallbladder drainage to ERCP (endoscopic retrograde cholangiopancreatography) reduces hospital admissions due to biliary disease in patients over 75 years old who have symptomatic choledocholithiasis and are not candidates for surgery. The study also aims to assess technical success rates, complications, mortality, and hospital costs over one year. Participants will be randomly assigned to one of two groups: one receiving ERCP with biliary sphincterotomy alone, and the other receiving ERCP with sphincterotomy plus transmural gallbladder drainage via a lumen-apposing metal stent (LAMS) placed endoscopically. The drainage procedure is performed during the same endoscopic session using ultrasound guidance and X-rays. Both groups undergo sedation with propofol and CO2 insufflation during the procedures. Follow-up will last one year, with multiple visits and phone calls scheduled to monitor progress and confirm stent position by ultrasound. Patients will attend four face-to-face visits at 1 day, 3 months, 6 months, and 12 months after the procedure, plus two phone calls at 7 days and 9 months. Clinical outcomes such as hospital readmissions for biliary causes, technical success, mortality, and healthcare costs will be tracked. The study is double-blind, so treating physicians and follow-up staff will not know which treatment was assigned. Adverse events will be monitored and classified according to established guidelines. Data will be anonymized and securely stored for analysis.