Stomach Neoplasms
Conditions
Keywords
Stomach neoplasms, Surgical site infection, Laparoscopic gastrectomy, Antimicrobial prophylaxis
Brief summary
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.
Detailed description
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.
Interventions
OTHERNo Antimicrobial prophylaxis
Antimicrobial prophylaxis are not administered during an operation
Sponsors
Korean South West East Gastric Surgery Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Histologically proven gastric adenocarcinoma clinical stage T1-2N0M0 patients who underwent laparoscopic distal gastrectomy * Age between 18 and 65 years * American Society of Anaesthesiologists (ASA) status \>2 * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Normal blood, liver, pulmonary, cardiac, and renal function * Informed consent
Exclusion criteria
* Administration of antibiotics within 1 month before surgery * Active infection at the time of surgery * Combined resection during operation (i.e., spleen, liver, colon, etc.) * History of upper abdominal surgery * Previous chemotherapy or radiotherapy within 6 months before surgery * Uncontrolled underlying comorbidities * Malnutrition with BMI less than 18.5 kg/m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative surgical site infection | Within postoperative 1 month | Incidence of surgical site infection, including superficial incisional, deep incisional, and organ/space infection, until postoperative 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative morbidity and mortality | Within postoperative 1 month or during hospitalization | Occurence of postoperative complications or deaths until postoperative 1 months or during hospitalization. Postoperative complications will be assessed with respect to types and severity. |
| Hospital stay | Up to 1month after operation | The duration of hospital stay from the operation to hospital discharge |
Countries
South Korea
Outcome results
None listed