RecruitingNot Applicable

The Pro-Chol Study

Denmark800 participantsStarted 2024-01-22

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Prediction model for resolution of pain

Timeframe: From baseline before surgery to follow-up at three months after surgery

Trial details

NCT IDNCT07245108

SponsorNordsjaellands Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-04

Contact for this trial

Daniel Mønsted Shabanzadeh, DMSc, PhD, MD

+45 48295796 daniel.moensted.shabanzadeh.01@regionh.dk