RecruitingNCT07245108

The Pro-Chol Study

The ProChol Study - Prospective Assessment of Symptoms Following Cholecystectomy in Patients With Symptomatic Uncomplicated Gallstones

Sponsor

Nordsjaellands Hospital

Enrollment

800 participants

Start Date

Jan 22, 2024

Study Type

OBSERVATIONAL

Conditions

Gallstones Cholecystolithiasis Gallstone Attack Uncomplicated Cholelithiasis

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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 Criteria5

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

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Interventions

PROCEDURELaparoscopic cholecystectomy

A surgical removal of the gallbladder through laparoscopy

PROCEDURELaparoscopic cholecystectomy

The 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.