Extended Antibiotic Therapy in Postoperative of Laparoscopic Cholecystectomy in Acute Cholecystitis

Study Overview
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Brief Summary
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Acute cholecystitis (AC) is a very common complication of cholelithiasis, encountered in 20% of symptomatic patients. Nowadays laparoscopic cholecystectomy (LC) is the standard treatment in mild and moderates forms of diseases and antibiotic therapy in the postoperatory of these patients remains under discussion. However in the beginning, AC presents itself as an steril process, the obstruction of the cystic duct initiates a cascade of inflammation, ischaemia and necrosis, as well as bacterial proliferation within the gallbladder lumen. Bactibilia was a significant factor associated with total, as well as infectious, operative complications. Regarding this, for some authors, monotherapy with amoxicillin clavulanic (AMC) would be the best treatment after LC in patients with mild and moderate cholecystitis without intraoperative complications such as bile peritonitis, cholangitis, gallbladder perforation or abscess. In the other hand, others do not prescribe antimicrobial treatment after surgery in these selected patients. There is controversy regarding the postoperative treatment with antibiotics in patients with mild and moderate cholecystitis and all the evidence about this topic. Therefore, investigators decided to conduct a prospective randomized study in patients undergoing laparoscopic cholecystectomy for acute mild and moderate cholecystitis cancer. The patients will be randomized to receive AMC or placebo after surgery. With this study investigators intend to prove that are no clinical differences in postoperative outcomes between patients treated with AMC and placebo. The primary aim of the trial is to assess that there are no benefits in the use of postoperative antibiotics in patients whit mild or moderate acute cholecystitis in whom a laparoscopic cholecystectomy was performed.

Detailed Description
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Double blind randomized clinical trial

Official Title
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Extended Antibiotic Therapy in Postoperative of Laparoscopic Cholecystectomy Due to Acute Cholecystitis. Is it Necessary?

Conditions
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Acute Cholecystitis

Intervention / Treatment
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* Drug: Amoxicillin clavulanic
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 85 years old Patients with diagnose of mild or moderate acute cholecystitis. Underwent laparoscopic cholecystectomy on Italian Hospital of Buenos Aires Exclusion Criteria: They refuse to participate from the trial or the process of informed consent. Have known allergies or hypersensitivity to Mosapride or lactose (used for placebo). Patients with severe cholecystitis Patients with moderate cholecystitis who presents liver abscess, gallbladder abscess, cholangitis or bile peritonitis. Intraoperative findings like liver cancer, liver metastases, common bile duct stones or gallbladder carcinoma. Patients with conversion to laparotomy Previous treatment with antibiotics for more than five days. Patients with active oncological diseases, AIDS, diabetes, transplanted.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A (Amoxicillin Clavulanic)<br>Intake of active drug (Amoxicillin Clavulanic). 3 g per day divided into 3 oral intakes of 1 g each (2 pill of Amoxicillin Clavulanic every 8 hrs). This treatment will begin on postoperative day 1 for 5 days. | Drug: Amoxicillin clavulanic<br>* 3 g per day divided into 3 oral intakes of 1 g each (2 pill of Amoxicillin Clavulanic every 8 hrs). This treatment will begin on postoperative day 1 for 5 days.<br>* Other names: Optamox;|
| Placebo Comparator: Placebo<br>Intake of placebo (Lactose). 1 pill of the same characteristics as Amoxicillin clavulanic every 8 hs. This will begin on postoperative day 1 for 5 days. | Drug: Placebo<br>* 1 pill of the same characteristics as Amoxicillin clavulanic every 8 hs. This will begin on postoperative day 1 for 5 days.<br>* Other names: Lactose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of infectious postoperative complications | Incidence of infectious postoperative complications in patients who underwent a laparoscopic cholecystectomy due to acute mild and moderate cholecystitis, with antibiotics or placebo | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days of hospital stay or readmissions. | To evaluate hospital stay. | 30 days | 
| Number of surgical reinterventions or reoperations. |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute cholecystitis., Amoxicillin clavulanic