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Transabdominal and Laparoscopic Ultrasound in a Bariatric Setting

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened
    • Site details revised
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Every year, many patients undergo weight-loss (bariatric) surgery. While this surgery leads to significant and intended weight loss, it also increases the risk of developing gallstones or other gallbladder problems. Approximately one in five patients later requires a second operation to remove the gallbladder. This type of surgery carries a higher risk of complications and reoperations compared with gallbladder surgery performed in the general population. Preventive treatment may help reduce this risk. One option is medical treatment with Ursochol, which has been shown to lower the risk of developing gallstones after bariatric surgery. However, this treatment is only effective in patients who have not already developed gallstones before surgery. This means patients need a reliable preoperative ultrasound examination of the gallbladder. Unfortunately, performing ultrasound can be technically challenging in patients with obesity, making it harder to detect small stones or other abnormalities. The goal is therefore to improve the examination of the gallbladder in patients undergoing bariatric surgery in order to better identify who may benefit from preventive treatment. The study The investigators are comparing two types of ultrasound examination of the gallbladder: * Standard ultrasound performed on the outside of the abdomen using a handheld probe. * Laparoscopic ultrasound performed during bariatric surgery using a small ultrasound probe placed inside the abdomen, typically placed on the liver near the gallbladder. It is of interest to find out whether the ultrasound performed during surgery finds more: * Gallstones * Sludge * Small stones (microlithiasis) * Thickening of the gallbladder wall By improving detection, the investigators aim to better guide preventive treatment and reduce the need for future gallbladder surgery.
Trial Details
NCT Number NCT07453186
Lead Sponsor Esbjerg Hospital - University Hospital of Southern Denmark
Conditions
(from sponsor)
Gallstone Disease, Ultrasonic Diagnosis, Bariatric Patients Undergoing Bariatric Surgery
Related terms Cholelithiasis, Gallbladder Diseases
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov