Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sohag University | OTHER |
Not provided
Not provided
Not provided
Not provided
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. 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| early cholecystectomy | Active Comparator | Early cholecystectomy was done within 48 after admission |
|
| delayed cholecystectomy | Sham Comparator | Delayed cholecystectomy was done after 30 days after randomization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| early cholecystectomy | Procedure | cholecystectomy was done within 48 after admission |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gallstone related complications | recurrent pancreatitis, cholecystitis, cholangitis, obstructive choledocholithiasis needing endoscopic retrograde cholangiopancreatography, or gallstone colic | 6 month of onset of pancreatitis |
| Measure | Description | Time Frame |
|---|---|---|
| Difficulty of cholecystectomy | the degree of difficulty of the procedureas assessed by the most experienced surgeon on a 0-10 visual analogue scale | up to 3 hours |
| Conversion to open cholecystectomy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| delayed cholecystectomy | Procedure | cholecystectomy was done after 30 days after randomization |
|
| up to 2 hours |
| Operative time | from the begging of the operation to recovery of patient | up to 10 hours |
| Cholecystectomy related complications | up to 1 month |
| additional surgical, endoscopic, or radiological intervention | up to 6 month |
| Gall stones non related complications | up to 6 month |
| Length of hospital stay of index admission | from admission to discharge of patient, up to 10 days |
| Number of readmission | up to 6 month |
| Total length of hospital stay (including readmission) | up to 6 month |
| The number of patient-reported colics irrespective of readmission | up to 6 month |
| Need for intensive care unit admission | up to 6 month |
| Mortality | death from gall stone related complication | up to 6 month |