In patients with mild gallstone pancreatitis, early cholecystectomy within 48 hours might reduce the risk of recurrent gallstone-related complications, compared with the more commonly used strategy in our locality of conservative management and delayed cholecystectomy. However, evidence to support early cholecystectomy is poor, and concerns exist about an increased risk of cholecystectomy-related complications with this approach. In this study, we aimed to compare the benefits and harms of early versus delayed cholecystectomy in patients with mild biliary pancreatitis.
Inclusion criteria 1. Patient diagnosed with a first attack of mild biliary pancreatitis 2. Age ≥ 18 years 3. American Society of Anesthesiologists (ASA) grade I, II or III 4. a serum C-reactive protein (CRP) concentration less than 100 mg/L, 5. no need for opioid analgesics, 6. normal oral diet tolerance Exclusion criteria 1\. chronic pancreatitis 2. alcohol abuse 3. pregnancy The number of patients needed was calculated. Considering a power of 80% and reliability of 0.05, we found that 53 patients should be present in each group. Eligible patients will be randomly divided into two equal groups (Group 1: early cholecystectomy, Group 2: delayed cholecystectomy) according to a computer-generated random numbers. Procedure Early cholecystectomy was done within 48 after admission. Delayed cholecystectomy was done after 30 days after randomization. All cholecystectomies were done by, or under the direct supervision of, a surgeon who had undertaken at least 100 cholecystectomies in the past 5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
2
cholecystectomy was done within 48 after admission
cholecystectomy was done after 30 days after randomization
Gallstone related complications
recurrent pancreatitis, cholecystitis, cholangitis, obstructive choledocholithiasis needing endoscopic retrograde cholangiopancreatography, or gallstone colic
Time frame: 6 month of onset of pancreatitis
Difficulty of cholecystectomy
the degree of difficulty of the procedureas assessed by the most experienced surgeon on a 0-10 visual analogue scale
Time frame: up to 3 hours
Conversion to open cholecystectomy
Time frame: up to 2 hours
Operative time
from the begging of the operation to recovery of patient
Time frame: up to 10 hours
Cholecystectomy related complications
Time frame: up to 1 month
additional surgical, endoscopic, or radiological intervention
Time frame: up to 6 month
Gall stones non related complications
Time frame: up to 6 month
Length of hospital stay of index admission
Time frame: from admission to discharge of patient, up to 10 days
Number of readmission
Time frame: up to 6 month
Total length of hospital stay (including readmission)
Time frame: up to 6 month
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The number of patient-reported colics irrespective of readmission
Time frame: up to 6 month
Need for intensive care unit admission
Time frame: up to 6 month
Mortality
death from gall stone related complication
Time frame: up to 6 month