Is it Safe to do Laparoscopic Cholecystectomy for Acute Cholecystitis up to Seven Days?

Study Overview
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Brief Summary
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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.

Official Title
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Is it Safe to do Laparoscopic Cholecystectomy for Acute Cholecystitis up to Seven Days? A Randomized Clinical Trial

Conditions
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Acute Cholecystitis

Intervention / Treatment
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* Procedure: Early laparoscopic cholecystectomy
* Procedure: Late laparoscopic cholecystectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with AC within seven days from symptom onset American Society of Anesthesiologist (ASA) physical status ≤ II Age from 21 to 60 years Exclusion Criteria: Patients with ASA physical status > II Age < 21 years or > 60 years Child classification B or C Choledocholithiasis Acute pancreatitis Severe sepsis Gallbladder perforation Pregnant women

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group E: Early LC (n=60)<br>Early laparoscopic cholecystectomy (within 72h from symptom onset) | Procedure: Early laparoscopic cholecystectomy<br>* within 72h from symptom onset<br>|
| Active Comparator: Group L: Late LC (n=60)<br>Late laparoscopic cholecystectomy (after 72h up to seven days from symptom onset) | Procedure: Late laparoscopic cholecystectomy<br>* after 72h up to seven days from symptom onset<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute cholecystitis, Early laparoscopic cholecystectomy, Gallbladder disease, Late laparoscopic cholecystectomy