Status:
COMPLETED
No Antimicrobial Prophylaxis for Laparoscopic Distal Gastrectomy
Lead Sponsor:
Korean South West East Gastric Surgery Group
Conditions:
Stomach Neoplasms
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 SS...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT02200315
Start Date
May 1 2014
End Date
September 1 2015
Last Update
February 3 2016
Active Locations (3)
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1
Chonnam National University Hwasun Hospital
Hwasun-eup, Jeollanam-do, South Korea, 519-809
2
Dong-A University Hospital
Busan, Kyungsang-do, South Korea, 602-715
3
Kyemyung University Dongsan Medical Center
Daegu, Kyungsang-do, South Korea, 700-712