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Transabdominal and Laparoscopic Ultrasound in a Bariatric Setting

NCT07453186 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-06-02

No results posted yet for this 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.

Conditions

  • Gallstone Disease
  • Ultrasonic Diagnosis
  • Bariatric Patients Undergoing Bariatric Surgery

Interventions

DIAGNOSTIC_TEST

Diagnostic procedures

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

Sponsors & Collaborators

  • Esbjerg Hospital - University Hospital of Southern Denmark

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2028-06-01
Completion
2029-03-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07453186 on ClinicalTrials.gov