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
This trial does not accept healthy volunteersQualifiers
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 population
The population will include patients referred to outpatient clinics either from primary care general practitioners or from a hospital department. Currently six hospitals are included from four out of five Danish health care regions.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Laparoscopic cholecystectomy
Procedure/SurgeryA surgical removal of the gallbladder through laparoscopy
Laparoscopic cholecystectomy
Procedure/SurgeryThe intervention is intended laparoscopic cholecystectomy. Patients that undergo conversion to open (traditional) cholecystectomy will still be included. Patients scheduled for open cholecystectomy will not be included.
Treatment groups
800 Participants
are divided into 1 treatment groupGroup A: Patients with gallbladder stones and biliary pain that undergo laparoscopic cholecystectomy1 intervention
Trial outcomes
Primary outcomes
1
Prediction model for resolution of pain
To build and validate a prediction model for resolution of pain (VAS≤4) following laparoscopic cholecystectomy
Time frame
From baseline before surgery to follow-up at three months after surgerySecondary outcomes
1
Changes in symptoms following surgery
To explore the changes in symptoms following cholecystectomy as defined through 1. core symptoms of the GIQLI questionnaire (such as dyspeptic symptoms, diarrhea, and constipation); 2. GIQLI quality of life total scores.
Time frame
From baseline before surgery to follow-up at three months after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
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