Actively Recruiting
Transabdominal and Laparoscopic Ultrasound in a Bariatric Setting: Utility and Diagnostic Accuracy
Led by Esbjerg Hospital - University Hospital of Southern Denmark · Updated on 2026-06-02
130
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of two ultrasound methods to detect gallbladder problems in patients undergoing bariatric surgery for severe obesity. This study aims to improve detection of gallstones and other gallbladder issues that often occur after such surgery. The goal is to better guide preventive treatments and reduce the need for future gallbladder surgery, addressing the challenges of current ultrasound techniques in obese patients. Participants will receive two types of ultrasound examinations: standard transabdominal ultrasound performed on the outside of the abdomen by two independent specialists before surgery, and laparoscopic ultrasound performed during bariatric surgery by two surgeons using a probe placed inside the abdomen. Both ultrasound methods are done independently and blinded, with the laparoscopic ultrasound adding about 5-10 minutes to the surgical procedure. During the study, participants will have two transabdominal ultrasounds on the same day before surgery and two laparoscopic ultrasounds during surgery. Researchers will compare the detection of gallbladder pathology between these methods and assess interobserver agreement, examination time, and image quality. The main outcome is whether gallbladder pathology is detected, and the study plans to enroll 130 patients. Data will be securely stored and analyzed, and results will be published regardless of outcome.
CONDITIONS
Brief Title
Transabdominal and Laparoscopic Ultrasound in a Bariatric Setting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age �3E= 18 years
- Scheduled for bariatric surgery
- Able to provide informed consent
You will not qualify if you...
- Previous cholecystectomy
- Previous biliary surgery
- Previous liver surgery
- Inability to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 31 days before surgery
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility and scheduling
Duration - Same day
Participants undergo two independent transabdominal ultrasound examinations performed on the same day by different radiologists to detect gallbladder pathology before surgery.
1 visit (in-person) with 2 ultrasound examinations
Duration - Duration of planned bariatric surgery plus 5-10 minutes for ultrasound
During bariatric surgery, participants receive two independent laparoscopic ultrasound examinations performed by surgeons to assess gallbladder pathology.
Ultrasound examinations performed intraoperatively
Trial Site Locations
Total: 1 location
1
Esbjerg og Grindsted Sygehus
Esbjerg, Denmark, 6700
Actively Recruiting
Research Team
B
Benjamin Petersen, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here