Acute Cholecystitis
Conditions
Keywords
Acute cholecystitis., Amoxicillin clavulanic
Brief summary
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
Double blind randomized clinical trial
Interventions
DRUGAmoxicillin 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.
DRUGPlacebo
1 pill of the same characteristics as Amoxicillin clavulanic every 8 hs. This will begin on postoperative day 1 for 5 days.
Sponsors
Hospital Italiano de Buenos Aires
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of infectious postoperative complications | 30 days | Incidence of infectious postoperative complications in patients who underwent a laparoscopic cholecystectomy due to acute mild and moderate cholecystitis, with antibiotics or placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of days of hospital stay or readmissions. | 30 days | To evaluate hospital stay. |
| Number of surgical reinterventions or reoperations. | 30 days | — |
Countries
Argentina
Outcome results
None listed