Not provided
Not provided
Not provided
Not provided
There were difficulties in implementation
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is a multi-center, double-blinded, randomized (1:1) clinical trial. The aim is to compare the postoperative infection rate between the 3 days postoperative AMP group and the placebo group in HCC patients undergoing hepatectomy.
This trial includes two phase. The first phase is the internal pilot study to explore the expulsion rate and recruited population. The second phase is the main phase III trial.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postoperative antimicrobial prophylaxis | Experimental | Patients will receive postoperative antimicrobial prophylaxis for 3 days in 24 hours after hepatectomy. |
|
| No postoperative antimicrobial prophylaxis | Sham Comparator | Patients will receive no antibiotics after hepatectomy, unless the clinicians suggest he/she need antibiotics to treat or prevent infection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| postoperative antimicrobial prophylaxis | Drug | The drugs are all common antibiotics used to prevent postoperative infection in each hospital. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 30-day postoperative infection rate | the incidence rate of postoperative infection occurred in 30 days after surgery, including surgical site infections, distant infection or infection from unknown sources | 30 days after hepatectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site infection rate | the incidence rate of surgical site infection, including infections of the incision or organ or space that occur after surgery. | 30 days after hepatectomy |
| Postoperative complication rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
| No postoperative antimicrobial prophylaxis | Other | Patients will receive no antibiotics after hepatectomy unless necessary. |
|
the incidence rate of postoperative complications, grading as Clavien-Dindo grades
| 3 months after hepatectomy |
| Severe infection rate | the incidence rate of postoperative complications over grade 3 | 30 days after hepatectomy |
| Distant infection rate | the incidence rate of distant infections, including respiratory system infection, urinary system infection, catheter related infections or sepsis (defined as fever (temperature ≥38 ℃) or elevated white blood cell (> 10 x10^9 / L) accompanied by sputum, urine, catheter secretions, or blood culture positive. | 30 days after hepatectomy |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
Not provided
Not provided