A Phase 4 interventional study of Amoxicillin clavulanic and Placebo in Acute Cholecystitis, sponsored by Hospital Italiano de Buenos Aires. Completed at 1 site in Argentina. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-02-27.
Sponsored by Hospital Italiano de Buenos Aires · Phase 4, Interventional, and Treatment
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.
Double blind randomized clinical trial
266 studies on the registry are indexed under Cholecystitis; 46 are open to participants now.
This study's enrollment of 200 is above the median of 86 across 167 interventional studies indexed under Cholecystitis.
Browse Cholecystitis studies →Hospital Italiano de Buenos Aires is the lead sponsor of 128 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
Also known as: Optamox
1 pill of the same characteristics as Amoxicillin clavulanic every 8 hs. This will begin on postoperative day 1 for 5 days.
Also known as: Lactose
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
Time frame: 30 days
Number of days of hospital stay or readmissions.
To evaluate hospital stay.
Time frame: 30 days
Number of surgical reinterventions or reoperations.
Time frame: 30 days
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Hospital Italiano de Buenos Aires