Laparoscopic Cholecystectomy in Management of ACC Within Versus After 3 Days

Study Overview
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Brief Summary
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This study was aimed to assess the outcome of laparoscopic cholecystectomy in acute calculous cholecystitis in terms of conversion rates, postoperative complications and length of hospital stay within and after 3 days of symptoms onset.

Detailed Description
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The study aims to evaluate the safety and competency of laparoscopic cholecystectomy as surgical management of acute calculous cholecystitis within and after 72h of symptom onset. This study included 62 patients with acute calculous cholecystitis. Patients are divided into 2 study groups by the time of laparoscopic cholecystectomy comparing to the onset of symptoms and categorized as Group A & B. Immediate laparoscopic cholecystectomy is performed in Group A. while late laparoscopic cholecystectomy is performed in Group B. Patients in both groups monitored since admission, during operations, and along the postoperative period.

Official Title
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Laparoscopic Cholecystectomy for Management of Acute Calculous Cholecystitis Within Versus After 3 Days of Disease Onset

Conditions
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Acute Calculous Cholecystitis

Intervention / Treatment
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* Procedure: Laparoscopic cholecystectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Abdominal pain characteristic of Acute Cholecystitis, Positive Murphy's sign, Total Leucocyte Count > 10,000/ uL, and (4) Ultra-sonographic evidence of Acute Calculous Cholecystitis. Initial surgical management planned for immediate laparoscopic cholecystectomy. Patients who are fit for laparoscopy and general anesthesia. Patient who agree to provide short term outcome data and agree to provide contact information. Exclusion Criteria: Patients with ultra-sonographic findings of common bile duct calculi, pancreatitis, gall bladder perforation, gall bladder gangrene or gall bladder abscess. Patients with other associated abdominal pathology. Patients with any previous abdominal surgery or any significant systemic disease. Septic shock. Pregnancy/ Breast-feeding mothers. Participation in an additional drug or device study and inability to offer informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 62 patients with acute calcular cholecystitis are divided into 2 study groups by the time of laparoscopic cholecystectomy comparing to onset of symptoms
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LC within 72 hours of disease onset<br>Immediate laparoscopic cholecystectomy within 72 hours of the onset of symptoms was performed in these patients | Procedure: Laparoscopic cholecystectomy<br>* The use of laparoscopic cholecystectomy in management of acute calculous cholecysitits<br>|
| Active Comparator: LC after 72 hours of disease onset<br>Late laparoscopic cholecystectomy after 72 hours of the onset of symptoms was performed in these patients | Procedure: Laparoscopic cholecystectomy<br>* The use of laparoscopic cholecystectomy in management of acute calculous cholecysitits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between early and late laparoscopic cholecystectomy regarding Operation time | comparing the needed intra-operative time for laparoscopic cholecystectomy within and after 3 days of the onset of acute calcular cholecystitis , time will be measured by minutes | intra-operative | 
| Comparison between early and late laparoscopic cholecystectomy regarding difficulty of operation | comparing the difficulty of laparoscopic cholecystectomy within and after 3 days of the onset of acute calculous cholecystitis, difficulty will be assessed by the rate of conversion to open cholecystectomy | intra-operative | 
| comparison between early and late laparoscopic cholecystectomy regarding post operative pain | comparing between laparoscopic cholecystectomy within and after 3 days of the onset of acute cholecystitis regarding the presence and duration of post operative pain , pain will be measured by either the pain responded to regular NSAIDs or needed the administration of narcotics | within 1month post operative | 
| Duration of postoperative hospital stay | comparing post-operative duration of hospital stay after laparoscopic cholecystectomy within and after 3 days of the onset of acute calcular cholecystitis ,duration will be measured by post operative days spent in the hospital | within 2 weeks post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison between early and late laparoscopic cholecystectomy regarding post operative bile leakage | compare between laparoscopic cholecystectomy within and after 3 days of the onset of acute cholecystitis regarding the presence and amount of bile leakage | first 72 hours post-operative | 
| comparison between early and late laparoscopic cholecystectomy regarding post operative bleeding | compare between laparoscopic cholecystectomy within and after 3 days of the onset of acute cholecystitis regarding the presence and amount of postoperative bleeding | 7 days postoperative | 
| presence of any wound complication by examining the wound | comparison between early and late laparoscopic cholecystectomy concerning the presence and rate of wound infection by clinical examination post-operative | within 10 days post-operative | 

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