No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
800 (estimated)
Sponsor
Nordsjaellands Hospital · Other
Who this trial is looking for
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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 …
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.
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Eligibility Criteria
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 chol…
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
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