The ProChol Study - Prospective Assessment of Symptoms Following Cholecystectomy in Patients With Symptomatic Uncomplicated Gallstones

What this Trial Is About

Researchers are evaluating patients with gallstones and abdominal pain who are scheduled to have their gallbladder removed using laparoscopic cholecystectomy. The study aims to collect information on quality of life, abdominal pain, gallstone disease, and patient characteristics to predict which patients will have pain relief after surgery. This observational study will include adults over 18 years old and will be conducted in surgical hospitals across Denmark. Participants will undergo their planned laparoscopic gallbladder removal, including cases where surgery is converted to open cholecystectomy. No changes to the standard treatment will be made by the study. Patients will be studied before surgery and then followed for three months afterward to assess their symptoms and pain resolution. The study plans to develop and validate a prediction model to help clinicians and patients decide about surgery. During the study, data will be collected from medical records and online questionnaires before surgery and at the three-month follow-up. If questionnaires are not completed within a week, reminders will be sent. Researchers will measure symptom changes and use these to create a pain relief prediction score. The study will last about two to three years to include enough participants, with a total of 800 planned for model development and validation.

The Pro-Chol Study