Clinical Trial: Extended Antibiotic Therapy in Postoperative of Laparoscopic Cholecystectomy in Acute Cholecystitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 ch

Detailed Summary: Double blind randomized clinical trial
Sponsor: Hospital Italiano de Buenos Aires

Current Primary Outcome: Incidence of infectious postoperative complications [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of days of hospital stay or readmissions. [ Time Frame: 30 days ]
    To evaluate hospital stay.
  • Number of surgical reinterventions or reoperations. [ Time Frame: 30 days ]


Original Secondary Outcome: Same as current

Information By: Hospital Italiano de Buenos Aires

Dates:
Date Received: February 5, 2014
Date Started: February 2014
Date Completion: December 2017
Last Updated: December 16, 2015
Last Verified: December 2015