The aim of this study is to evaluate the feasibility and safety of no use of antimicrobial prophylaxis during laparoscopic distal gastrectomy for gastric carcinoma.
This is a phase II clinical trial investigating the postoperative surgical site infection (SSI) rates after no antimicrobial prophylaxis use during laparoscopic distal gastrectomy. Target ranges of SSI rates after laparoscopic distal gastrectomy were determined based on the previous reports and our data. If SSI rates are within the target range, the investigators will proceed to a randomized controlled trial investigating the efficacy of no antimicrobial use for laparoscopic gastrectomy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
98
Antimicrobial prophylaxis are not administered during an operation
Chonnam National University Hwasun Hospital
Hwasun-eup, Jeollanam-do, South Korea
Dong-A University Hospital
Busan, Kyungsang-do, South Korea
Kyemyung University Dongsan Medical Center
Daegu, Kyungsang-do, South Korea
Postoperative surgical site infection
Incidence of surgical site infection, including superficial incisional, deep incisional, and organ/space infection, until postoperative 1 month
Time frame: Within postoperative 1 month
Postoperative morbidity and mortality
Occurence of postoperative complications or deaths until postoperative 1 months or during hospitalization. Postoperative complications will be assessed with respect to types and severity.
Time frame: Within postoperative 1 month or during hospitalization
Hospital stay
The duration of hospital stay from the operation to hospital discharge
Time frame: Up to 1month after operation
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