The Pro-Chol Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNordsjaellands Hospital
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 groupSponsors 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
Source ClinicalTrials.gov