Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis

Study Overview
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Brief Summary
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The ideal timing for ELC continues to be debatable in patients with acute calculator cholecystitis (ACC). This study was planned to identify the impact of different ELC timing in ACC on surgical outcomes in terms of safety and efficacy

Detailed Description
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This multicentric analysis involved of successive patients with ACC ELC between April 2018 and March 2020. Patients were divided into three groups according to the timing of the surgery: from the onset of symptoms within the first 3 days (group 1), between 4 and 7 days (group 2), and beyond 7 days (group 3). The primary outcome was the incidence of postoperative complications The secondary outcomes were conversion rate, blood loss, operative times, operational difficulty, the cost-benefit relationship, postoperative stay with each treatment line.

Official Title
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Assessment of Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis (Multicentric Study)

Conditions
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Acute Cholecystitis

Intervention / Treatment
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* Procedure: from the onset of symptoms within the first 3 days
* Procedure: : from the onset of symptoms within the 4-7 days
* Procedure: from the onset of symptoms beyond 7 days


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ACC patients who underwent early LC Exclusion Criteria: Pregnancy, Acalculous cholecystitis, CBDS, Ascending cholangitis, Pancreatitis, ASA score 4, Patients scheduled for DLC with failed medical treatment.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients with ACC were divided into three groups according to the timing of the surgery: from the onset of symptoms within the first 3 days (group 1), between 4 and 7 days (group 2) and beyond 7 days (group 3).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: from the onset of symptoms within the first 3 days (group 1)<br>ELC for ACC from the onset of symptoms within the first 3 days (group 1) | Procedure: from the onset of symptoms within the first 3 days<br>* ELC within 3 days of onset of ACC<br>* Other names: group 1;|
| Active Comparator: from the onset of symptoms within the 4-7 days<br>ELC for ACC from the onset of symptoms within the4-7 days (group II) | Procedure: : from the onset of symptoms within the 4-7 days<br>* ELC 4-7days of onset of ACC<br>* Other names: Group II;|
| Active Comparator: from the onset of symptoms beyond 7 days<br>ELC for ACC from the onset of symptoms beyond 7 days (group III) | Procedure: from the onset of symptoms beyond 7 days<br>* ELC after 7days of onset of ACC<br>* Other names: Group III;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of postoperative morbidity | the incidence of postoperative morbidity during the 30th day of postoperative procedure | 30 DAYS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| conversion rate | conversion rate to open cholecystectomy | INTRAOPERATIVE | 
| blood loss | blood loss | intraoperative | 
| hospital stay | overall hospital stay | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early laparoscopic cholecystectomy, postcholecystectomy bile injury, delay laparoscopic cholecystectomy