Extended Antibiotic Therapy in Postoperative of Laparoscopic Cholecystectomy in Acute Cholecystitis

Hospital Italiano de Buenos Aires

Status and phase: Completed; Phase 4

Conditions: Acute Cholecystitis

Treatments: Drug: Amoxicillin clavulanic; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02057679

2111

Details and patient eligibility

About

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.

Full description

Double blind randomized clinical trial

Enrollment: 200 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

Group A (Amoxicillin Clavulanic)

Active Comparator group

Description:

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.

Treatment:

Drug: Amoxicillin clavulanic

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo