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The trial aims to assess the value of two-regimen antibiotic prophylaxis versus placebo in elective laparoscopic cholecystectomy.
All patients enrolled will be submitted to laparoscopic cholecystectomy. The primary aim of the trial will be to assess the role of prophylactic i.v. infusion of ampicillin-sulbactam, ciprofloxacin, and placebo to reduce the rate of surgical site infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Intravenous infusion of 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy. |
|
| Ampicillin-sulbactam | Active Comparator | Intravenous infusion of 3gr ampicillin-sulbactam in 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy. |
|
| Ciprofloxacin | Active Comparator | Intravenous infusion of 400 mg ciprofloxacin in 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofloxacin | Drug | Prophylactic ciprofloxacin infusion before elective laparoscopic cholecystectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site infection | Surgical site infection defined according to the Centre of Disease Control (CDC) classification, recorded as 'yes' or 'no'. | 30 days after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Extra-abdominal infections | Extra-abdominal infections defined according to the CDC classification, recorded as 'yes' or 'no'. | 30 days |
| Adverse events. | Adverse events, defined as allergic reactions to antibiotics. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erasmo Spaziani, MD, PhD | University of Roma La Sapienza | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapienza University of Rome- Polo Pontino | Terracina | Latina | 04019 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21154360 | Background | Sanabria A, Dominguez LC, Valdivieso E, Gomez G. Antibiotic prophylaxis for patients undergoing elective laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2010 Dec 8;2010(12):CD005265. doi: 10.1002/14651858.CD005265.pub2. |
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| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| C035444 | sultamicillin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Ampicillin-sulbactam | Drug | Prophylactic ampicillin-sulbactam infusion before elective laparoscopic cholecystectomy |
|
| Placebo | Drug | Prophylactic placebo infusion before elective laparoscopic cholecystectomy |
|
| 30 days |
| Quality of life | Quality of life measured with the 36-Item Short Form Health Survey | 30 days |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |