Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID07453186

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age �3E= 18 years
  • Scheduled for bariatric surgery
  • Able to provide informed consent
Not Eligible

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

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Your Study Journey

Screening

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

Diagnostic Evaluation

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

Surgery and Immediate Diagnostic Evaluation

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

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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

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