Predicting pain relief after gallbladder removal

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective multicenter cohort of adults with ultrasound-confirmed uncomplicated gallstones scheduled for elective laparoscopic cholecystectomy across Danish surgical hospitals. Before surgery the study collects patient-reported measures (quality of life and detailed abdominal pain characteristics) along with routine clinical and imaging data. Outcomes, including pain resolution, are measured three months after surgery and analyzed to find determinants of persistent symptoms. The collected data will be used to develop and internally validate a clinical prediction score that combines patient-reported and readily available objective variables.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Ultrasound examination with presence of gallstones and description of size, number and presence of stones in infundibulum or cystic duct
* Abdominal symptoms believed to be caused by symptomatic uncomplicated gallstones
* Indication and candidate for elective laparoscopic cholecystectomy
* Above 18 years of age
* Ability to give oral and written consent
* Ability to understand, speak and read Danish
* Ability to receive digital post

Exclusion Criteria:

* History of complicated gallstone disease including acute cholecystitis, pancreatitis, common bile duct stones, or cholangitis
* Previous sphincterotomy
* Abnormal liver function test (ALAT/ASAT, alkaline phosphatase, bilirubin) without magnetic resonance cholangio-pancreatography or endoscopic ultrasound to rule out common bile duct pathology
* Indication for urgent cholecystectomy
* Current pregnancy

Where it's running

• Bispebjerg Hospital
  Copenhagen, Bispebjerg, Denmark Recruiting
• Aalborg Universitetshospital
  Aalborg, Denmark Recruiting
• Herlev Hospital
  Herlev, Denmark Recruiting
• Nordsjællands Hospital Hillerød
  Hillerød, Denmark Recruiting
• Regionshospital Nordjylland Hjørring
  Hjørring, Denmark Recruiting
• Hvidovre Hospital
  Hvidovre, Denmark Recruiting

Study contacts

• Principal investigator: Daniel Mønsted Shabanzadeh, DMSc, PhD, MD — Dansk: Offentligt hospital (inkl. universitetshospital)
• Study coordinator: Daniel Mønsted Shabanzadeh, DMSc, PhD, MD
• Email: daniel.moensted.shabanzadeh.01@regionh.dk
• Phone: +45 48295796

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.