Transabdominal and Laparoscopic Ultrasound in a Bariatric Setting

Condition(s) studied

Investigational drug(s) / intervention(s)

Diagnostic procedures: In the same patients, we will do both transabdominal and laparoscopic ultrasound

Study summary

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.

Eligibility

Primary outcome measure(s)

• Gallbladder pathology (yes / no) — From preoperative ultrasound (within 31 days before surgery) to laparoscopic ultrasound during bariatric surgery
  Composite endpoint consisting of gallstones (yes/no), slugde (yes/no), micro- lithiasis (yes/no), diffuse gallbladder wall thickness over 3 mm (yes/no).

Trial sites (1)

More Esbjerg Hospital - University Hospital of Southern Denmark trials in Denmark