Clinical Research Directory

Informing Patients About Their Surgery's Environmental Impact: an Effective Pathway to Sustainable Healthcare?

The healthcare sector contributes significantly to climate change. Reducing the number of patients receiving resource-intensive procedures such as surgery can lower carbon emissions, particularly when two treatments with comparable clinical outcomes are available. Nevertheless, the impact of incorporating environmental considerations into patients' decision-making processes remains underexplored. The investigators examine how including information about the environmental impact of treatment options in a gallstone decision aid affects patients' real-life choice between surgery and the more sustainable alternative of conservative treatment. Moreover, the investigators examine whether factors such as severity of symptoms moderate the relation between sustainability information and patients' treatment choice. An exploratory vignette study informed the hypotheses that will be tested among actual patients with gallstones making actual treatment decisions. The results of this ecologically valid study have implications for both clinical practice and healthcare policy by offering insight into the effectiveness of pathways to include patients in the transition towards sustainable healthcare.

Indocyanine Green Fluorescence During Fundus First Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy is the routine method for managing gallstone disease. This is considered a safe procedure with low risk of severe complications. Lesions to the deep bile ducts is, however, a rare complication from laparoscopic cholecystectomy that may have devastating consequences. The risk of bile duct injuries may be reduced by adapting the surgical approach. In general, the operation is started from the lower part of the gallbladder and continued upwards. It may, however, also be initiated from the top of the gallbladder and extended downwards. This approach, also termed fundus first, is routine at a few units. By injecting Indocyanin Green (ICG) that is excreted into the bile, the bile ducts may be visualized using near infrared light. This is a technique for mapping the anatomical structures adjacent to the gallbladder that has been used in previous studies for preventing bile duct injuries. This method has, however, not been tested at units where fundus first is the routine surgical technique. In the present randomized controlled trial, the investigators intend to evaluate the safety of ICG as a means for reducing the risk of bile duct lesions and to see if it works as intended. Altogether 294 operations for gallstones will be included in the study. The patients will be randomized to surgery with or without ICG. Regardless of the randomization, all operations will be undertaken with the fundus first technique. Thirty days after the operation, all data related to the operation are retrieved from the patient records by an assessor that does not know what group the patient was randomized to. The primary endpoint of the study is the time required from the start of the operation until intraoperative cholangiography is done. In addition, total operative time, all surgical complications and need for converting the operation to an open procedure will be recorded.

Diagnosis and Percutaneous Treatment of Biliary Tract Diseases

This study aims to implement and optimize the treatment of bile duct diseases in participants not eligible for endoscopic treatment using the Spyglass system, a system suitable for diagnostic and therapeutic endoscopic procedures in the pancreatic-biliary system, including the hepatic ducts. The main question it aims to answer is: \- Can the percutaneous cholangioscopic assisted technique resolve the biliary litiasis and/or perform endobiliary biopsies in less time than the traditional technique? Participants will undergo a colangioscopic-assisted treatment using the SpyGlass mini-endoscopic system at the Addomino-pelvic diagnostic and interventional radiology UOC of the Bologna University Hospital.

Post-Cholecystectomy Quality of Life

The study aims to identify factors associated with no increase in gastrointestinal quality of life after elective cholecystectomy for gallstones.