Short summary

Earlier studies have concluded that an increasing number of laparoscopic cholecystectomies are being carried out on a national scale. The main indiactaion for cholecystectomy in the uncomplicated cases with gallbladder stones is "socially debillitating pain" which is vaguely defined.
The objective of this study is to determine the indication for operation vs. conservative treatment with the following hypothesis:

Hypothesis:

• Only a minority of patients are advised conservative treatment
• The indications for surgery are not weldefined
• Socially debilitating pain is not welldescribed or defined

Rationale

Asymptomatic ("silent") gallbladder stones are a common phenomenon in the general population. A subgroup will eventually experience symptoms (E.g. abdominal pain) and even fewer will experience complications (E.g. cholecystitis), which is preferably treated with laparoscopic cholecystectomy under the main indication: "Socially debilitating pain". Earlier studies have shown that up to 47% of patients undergoing laparoscopic cholecystectomy will still experience symptoms after surgery, not to mention that about 1% experience major postoperative complications. Therefore, conservative treatment including weak analgesics as needed and observation might be a preferable alternative to operation in non-complicated cases that only suffer from mild or rare symptoms. Despite this, earlier studies have shown that the number of cholecystectomies in Denmark has increased from approximately 67 operations pr. 100.000 inhabitants in 1989 to 142 operations pr. 100.000 inhabitant s in 2003.
With this study we want to determine the indication for operation vs. conservative treatment in non-complicated gallstone disease patients. 

Description of the cohort

This study includes all patientens with symptomatic non-complicated gallstone disease, referede to Nyborg or Svendborg hospital for evaluation during the period from January 1, 2014 to December 31, 2015. Patients will be identified using the hospital diagnosis system (ICD-10). 

Data and biological material

Variables collected form each patient record:

• Background data: Age, gender, BMI.
• Clinical symptoms:
• Abdominal pain:
• Location
• Character within the past 3 months:
• Constant
• Daily
• > 1/week
• > 1/month
• Radiation of pain to: Back (yes/no) / Neck (yes/no)
• Duration of symptoms: > 3 month / > 6 month / > 1 year

Diagnostic tool:

• UL (ultrasonic verified gall bladder stone)
• Computed Tomography
• Magnetic resonance imaging 

Other information

• History with emergency admission(s) because of gallbladder stone disease (yes/no)
• Socially debilitating pain? (yes/no)*
• Does the patient prefere operation or conservative treatment?
• History with earlier laparotomy? (yes/no)
• History with gastrointestinal cancer? (yes/no)
• Raised Bilirubin or alkaline phosphatase?
• Raised temperature (>38.0 degrease celcius)?
• Other reason...

*If yes: Is socially debilitating pain described or explained in any way? (yes/no)

• Yes: What is the describtion/explanation?...

Co-morbidity (yes/no):

• Hypertension
• Diabetes (yes/no)
• Heart disease
• Liver disease
• Alcohol abuse (M:>21 units/week. F:>14 units/week)
• Kidney disease
• Lung disease

Exclusion criteria:

• Earlier admissions with or actuel verified:
• Choledocholithiasis, cholecystitis, cholangitis, pancreatitis
• Biochemical signs of cholestasis:
• Billirubin > 30umol/L
• Alkaline phosphatase > 120U/L
• Raised temperature during admission (T> 38,0).

Collaborating researchers and departments

Department of Surgery, Odense University Hospital

• Professor Niels Qvist, MD
• Staff specialist Mark Bremholm Ellebæk, PhD

Faculty of Health Sciences, University of Southern Denmark

• Medical student Benjamin Pedersen