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Objectives: To compare the safety of early (≤72h) versus late (>72h-7days) laparoscopic cholecystectomy (LC) from symptom onset for acute cholecystitis (AC).
Background: As LC within 72h of symptom onset was considered the optimum time, sometimes there was a delay in diagnosis and management. So, we raised the question of safety and feasibility of performing LC to patients with AC who failed to have LC within 72h of acute attack.
Patients and Methods: This was a prospective, randomized, double-blind, clinical trial; carried out on 120 patients presented with AC between September 2017 and April 2019. Patients were randomly allocated into two equal groups assigned to LC; group E: within 72h of symptom onset, and group L: after 72h up to seven days from symptom onset.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group E: Early LC (n=60) | Active Comparator | Early laparoscopic cholecystectomy (within 72h from symptom onset) |
|
| Group L: Late LC (n=60) | Active Comparator | Late laparoscopic cholecystectomy (after 72h up to seven days from symptom onset) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early laparoscopic cholecystectomy | Procedure | within 72h from symptom onset |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants and Rate of Post-operative complications | Number of participants and Rate of: Post-operative bleeding, Fluid collection, Bile leak, Port-site infection, Revision surgery, Mortality rate | 30 days post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Mean and Standard deviation of Operative duration (hours) (mean±SD) | Mean and Standard deviation of Operative duration (hours) | from surgical incision till suture closure |
| Mean and Standard deviation of Intra-operative blood loss (ml) (mean±SD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed M Abdalgaleil, MD | Damanhour Teaching Hospital | Principal Investigator |
| Ahmed M Shaat, MD | Damanhour Teaching Hospital | Principal Investigator |
| Osama S Elbalky, MD | Damanhour Teaching Hospital | Study Director |
| Mamdouh M Ibrahim, MD | Damanhour Teaching Hospital | Study Chair |
| Mohamed S Elnagar, MD | Damanhour Teaching Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Damanhour Teaching Hospital | Damanhūr | El-Beheira | Egypt |
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| ID | Term |
|---|---|
| D041881 | Cholecystitis, Acute |
| D005705 | Gallbladder Diseases |
| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| Late laparoscopic cholecystectomy |
| Procedure |
after 72h up to seven days from symptom onset |
|
Mean and Standard deviation of Intra-operative blood loss (ml)
| from surgical incision till suture closure |
| Number of participants and Rate of Conversion to open cholecystectomy | Number of participants and Rate of Conversion to open cholecystectomy | from the start till the end of surgical procedure |
| Mean and Standard deviation of Length of hospital stay (days) (mean±SD) | Mean and Standard deviation of Length of hospital stay (days) | from hospital admission till home discharge within 30 days |