Phase II Study of the Efficacy of no Antimicrobial Prophylaxis Use for Laparoscopic Distal Gastrectomy for Gastric Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 6
- 主要终点
- Postoperative surgical site infection
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Postoperative surgical site infection
时间窗: Within postoperative 1 month
Incidence of surgical site infection, including superficial incisional, deep incisional, and organ/space infection, until postoperative 1 month
次要结局
- Postoperative morbidity and mortality(Within postoperative 1 month or during hospitalization)
- Hospital stay(Up to 1month after operation)
研究者
Oh Jeong
Associate Professor
Korean South West East Gastric Surgery Group