Comparison the Influence of the Povidone-iodine or the Normal Saline Cleaning the Incision for the Incidence of the Surgical Site Infections for Gastric Cancer Patients With Gastrectomy- Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Superficial incisional surgical site infections
研究概览
简要总结
Surgical site infections (SSIs) is one of the most common complications of upper abdominal surgery. Previous studies found that type of surgical incision, emergency operation or not, surgical duration, age of patient, body mass index, malignance duration, malnutrition, complications (diabetes, shock, anemia et al) and drug (Long-term use of corticosteroids) are closely associated with the incidence of SSIs. The general incidence rate of SSIs was about 5% to 40%, although using the preoperative skin disinfectant and other methods to prevent and reduce the SSIs. And for the gastrointestinal surgery, due to the potential risk of infection, SSIs is an important problem which cannot be ignored. On the other hand, gastric cancer is one of the most common digestive system tumors, and gastrectomy is the primary therapeutic options. Therefore, it is important to compare the whether the different liquid (1% povidone-iodine solution or the 0.9% normal saline) wash the incision can influent the incidence of the SSIs.
详细描述
Standard Operating Procedure (SOP)
- Preoperative evaluation Patients satisfied with inclusion/exclusion criteria will be informed to join in the clinical study and signature the inform consent.
- Randomization: Preoperative evaluation found that total or subtotal gastrectomy can be performed, the case will entrance into the Randomization period. Random numbers are computer-generated, with the third party applications.
- Procedures: The surgical treatments is adopted the conventional open total or subtotal gastrectomy according to the Japanese Gastric Cancer treatments guidelines, 2010, Version 3. Patients in the Group A using the mixed solution with 400ml,0.9% normal saline and 100 ml，5%, povidone-iodine solution， and patients in the Group B with 500ml 0.9% normal saline solution to wash the abdominal surgical incision.
- Postoperative recovery: Postoperative recovery period need to collect those relevant parameters of all the patients. All the relevant parameters had definitely definition in the Case Report Form of this study which included the preoperative, intraoperative and postoperative clinicopathologic characteristics.
- Follow-up: Follow-up will last to the 30-day of the postoperative period. The postoperative complications is graded by the Clavien-Dindo classification. And the surgical site infections are the focus of this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preoperative endoscopy and biopsy confirmed gastric adenocarcinoma, and predictively feasible of conventional open total gastrectomy or subtotal gastrectomy;
- •Predictively resectable diseases, of preoperative staging JGCA 14th Edition cT1N0M0-T4aN+M0, Ia-IIIc stage
- •Age：≤75 years, or ≥18 years;
- •Without serious disease and malignance disease;
- •WHO performance score ≤2, ASA score ≤3;
- •No limit to sexual and race;
- •Informed consent required.
排除标准
- •Emergence operation, because of obstruction, perforate, acute hemorrhage and et al;
- •Patients with laparoscopic or laparoscopic-assisted gastrectomy
- •Patients with other severe complications cannot tolerate surgery: such as severe heart and lung diseases, heart function below clinical stage 2, uncontrollable hypertension, pulmonary infection, moderate to severe COPD, chronic bronchitis, severe diabetes and / or renal insufficiency, severe hepatitis and / or function below the rank of CHILD B grade, and severe malnutrition, etc;
- •Patients treated with neoadjuvant chemotherapy or radiation therapy which might affect the efficacy observation;
- •Severity mental diseases;
- •Primary lesion cannot be resected in the pattern of transabdominal gastrectomy, but for Whipple's procedure, or with a transthoracic approach surgery;
- •After signature the Clinical trial agreement, patients and their agent will quit the trial.
研究组 & 干预措施
Group A (povidone-iodine group)
The surgical incision is washed by the mixed solution with 400ml 9% normal saline and 100ml 5% povidone-iodine solution.
We declare that we have no conflicts of interest.
干预措施: Group A (povidone-iodine wash the surgical incision) (Procedure)
Group B (normal saline group)
The surgical incision is washed by the 500ml 0.9% normal saline.
We declare that we have no conflicts of interest.
干预措施: Group B (normal saline wash the surgical incision) (Procedure)
结局指标
主要结局
Superficial incisional surgical site infections
时间窗: 30-day of postoperative duration
The ceriteria for defining a surgical site infection adopt the defination of the Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee.Am J Infect Control. 1999;27(2):97-132; quiz 133-4; discussion 96.
次要结局
未报告次要终点
研究者
Jian-Kun Hu
Prof. of Gastrointestinal Surgery Department
West China Hospital