Clinical trial NCT02057679: Extended Antibiotic Therapy in Postoperative of Laparoscopic Cholecystectomy in Acute Cholecystitis
Official title: Extended Antibiotic Therapy in Postoperative of Laparoscopic Cholecystectomy Due to Acute Cholecystitis. Is it Necessary?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Cholecystitis
Keywords: Acute cholecystitis.
Amoxicillin clavulanic
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2014-02-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of infectious postoperative complications
timeFrame: 30 days
Secondary outcomes:
measure: Number of days of hospital stay or readmissions.
timeFrame: 30 days
measure: Number of surgical reinterventions or reoperations.
timeFrame: 30 days
Other outcomes:
Locations:
city: Capital Federal
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Buenos Aires
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Martin de Santibañes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Italiano de Buenos Aires
name: Diego Giunta, MD
role: STUDY_DIRECTOR
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