A Randomized Trial of Abdominal Wound Drainage in Obese Gynecologic Oncology Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Prevalence of surgical site infection
研究概览
简要总结
The aim of the present randomized trial is to assess the efficacy of wound drains in terms of reducing the rates of surgical site infection in obese patients with gynecological cancer.
详细描述
Many prophylactic methods have been suggested for the treatment of surgical wound infections, including the prolonged administration of antibiotics as well as the use of subcutaneous tissue drainage, the use of which has been shown to be particularly effective in overweight patients. While its importance seems to be moderate in obese patients as well as those that suffer from malignant disease, to date, it remains unknown if wound drains may help reduce the rates of surgical site infection in obese patients that suffer from cancer. In the field of gynecological oncology data are limited to anachronistic studies whose methodological value is limited; hence, guidelines are primarily based in data of high risk of bias as to date, the value of subcutaneous tissue drainage in obese women undergoing surgery for gynecological cancer has not been documented in a large randomized study.
Considering the significant impact of surgical site infection on the interval to adjuvant therapy (as patients with infectious diseases cannot receive chemotherapy or radiotherapy), it becomes evident that every effort has to be made in order to help reduce the rates of SSI to help maintain acceptable intervals that will ensure appropriate care of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The statistician involved in the statistical analyses of results will be blinded to the arm of treatment
入排标准
- 年龄范围
- 30 Years 至 85 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •This prospective randomized study will include obese (BMI> 35) patients who will undergo primary surgery for ovarian or endometrial cancer
排除标准
- •Immunodeficient patients (systemic disease including HIV infection, systemic lupus erythematosus etc) Patients with hematologic diseases
结局指标
主要结局
Prevalence of surgical site infection
时间窗: Within 30 days
Surgical site infection will be defined as redness, swelling, pain, bleeding, or any discharge from the surgical site
Risk of surgical debridement of surgical site infection
时间窗: Within 30 days
Rates of surgical intervention to treat surgical site infection will be recorded
次要结局
- Risk of wound dehiscence(Within 30 days)
- Length and depth of wound dehiscence(Within 30 days)
- Risk of seroma formation(Within 30 days)
- Duration of antibiotic therapy directed against surgical site infection(Within 30 days)
- Re-admission rates(Within 30 days)
- Interval to adjuvant therapy(Within 30 days)
- Risk and duration of fever related to surgical site infection(Within 30 days)
- Duration of hospitalization(Within 30 days)
研究者
Dimitrios Haidopoulos
Associate Professor of Obstetrics and Gynecology
Alexandra Hospital
