Postoperative Antimicrobial Prophylaxis Versus Placebo for Infection Prevention in HCC After Liver Resection (HCC)
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|ClinicalTrials.gov Identifier: NCT03990974|
Recruitment Status : Not yet recruiting
First Posted : June 19, 2019
Last Update Posted : June 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma Postoperative Infection||Drug: postoperative antimicrobial prophylaxis Other: No postoperative antimicrobial prophylaxis||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||458 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Postoperative Antimicrobial Prophylaxis Versus Placebo for Infection Prevention in Hepatocellular Carcinoma After Liver Resection: A Multi-center, Randomized, Open-labelled Trial.|
|Estimated Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||July 1, 2020|
Experimental: Postoperative antimicrobial prophylaxis
Patients will receive postoperative antimicrobial prophylaxis for 3 days in 24 hours after hepatectomy.
Drug: postoperative antimicrobial prophylaxis
The drugs are all common antibiotics used to prevent postoperative infection in each hospital.
Sham Comparator: No postoperative antimicrobial prophylaxis
Patients will receive no antibiotics after hepatectomy, unless the clinicians suggest he/she need antibiotics to treat or prevent infection.
Other: No postoperative antimicrobial prophylaxis
Patients will receive no antibiotics after hepatectomy unless necessary.
- 30-day postoperative infection rate [ Time Frame: 30 days after hepatectomy ]the incidence rate of postoperative infection occurred in 30 days after surgery, including surgical site infections, distant infection or infection from unknown sources
- Surgical site infection rate [ Time Frame: 30 days after hepatectomy ]the incidence rate of surgical site infection, including infections of the incision or organ or space that occur after surgery.
- Postoperative complication rate [ Time Frame: 3 months after hepatectomy ]the incidence rate of postoperative complications, grading as Clavien-Dindo grades
- Severe infection rate [ Time Frame: 30 days after hepatectomy ]the incidence rate of postoperative complications over grade 3
- Distant infection rate [ Time Frame: 30 days after hepatectomy ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03990974
|Contact: Ming Kuang, PhD.||008687755766 ext firstname.lastname@example.org|