About this trial

This prospective clinical cohort study will include patients with gallstones and abdominal pain scheduled for surgery (laparoscopic cholecystectomy). Data on quality of life, abdominal pain, gallstone disease, and patient characteristics will be collected before surgery. The outcomes will be assessed three months following surgery and will primarily be determinants for resolution of pain. The aim is to make a prediction score that may aid clinicians and patients in decision making about surgery.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Laparoscopic cholecystectomy
  • Laparoscopic cholecystectomy

Treatment groups

800 Participants
are divided into 1 treatment group

Locations

7
Bispebjerg Hospital2400, CopenhagenBispebjerg, Denmark
Aalborg Universitetshospital9000, Aalborg Denmark
Herlev Hospital2730, Herlev Denmark
Nordsjællands Hospital Hillerød3400, Hillerød Denmark

Sponsors and collaborators

Nordsjaellands Hospital

Lead sponsor

Hvidovre University Hospital

Collaborator

Copenhagen University Hospital at Herlev

Collaborator

Aalborg University Hospital

Collaborator

Viborg Regional Hospital

Collaborator

Zealand University Hospital

Collaborator

University Hospital Bispebjerg and Frederiksberg

Collaborator

Regionshospital Nordjylland

Collaborator

Regionshospitalet Viborg, Skive

Collaborator