A Multicenter Randomized Clinical Trial Comparing Prophylactic Mesh Placement Versus Primary Closure, With or Without Negative Pressure Wound Therapy, in Patients Undergoing Primary or Interval Cytoreductive Surgery for Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Incidence of Incisional Hernia
研究概览
简要总结
Incisional hernia is a common complication after midline laparotomy and may significantly impact quality of life, morbidity, and healthcare costs. Patients undergoing cytoreductive surgery for ovarian cancer are considered at increased risk due to extensive surgical procedures, nutritional status, and exposure to systemic treatments.
This prospective randomized clinical trial aims to evaluate whether prophylactic mesh placement during abdominal wall closure reduces the incidence of incisional hernia compared with conventional fascial closure in women undergoing cytoreductive surgery for ovarian cancer through a midline laparotomy. To control for the potential effect of negative pressure wound therapy (NPWT) on surgical site infection, participants will also be randomized to receive NPWT or standard wound dressing, resulting in four treatment arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients diagnosed with ovarian carcinoma.
- •Undergoing primary cytoreductive surgery, interval cytoreductive surgery, or delayed cytoreductive surgery after six cycles of chemotherapy.
- •Surgical procedure performed through a midline laparotomy.
- •Ability and willingness to provide written informed consent.
排除标准
- •Surgery for recurrent ovarian cancer (secondary, tertiary, or subsequent cytoreductions).
- •Minimally invasive surgical approach.
- •Planned secondary cytoreductive surgery during the 24-month follow-up period.
- •Inability or unwillingness to comply with follow-up requirements.
结局指标
主要结局
Incidence of Incisional Hernia
时间窗: 24 months after surgery
Presence of an abdominal wall incisional hernia confirmed by computed tomography (CT scan) or by imaging performed after clinical suspicion during follow-up.
次要结局
- Incidence of Surgical Site Infection(Within 30 days after surgery)
- Incidence of Incisional Hernia at Intermediate Time Points(3, 6, and 12 months after surgery)
- Risk Factors Associated With Incisional Hernia Development(Up to 24 months)
研究者
Jose Luis Sanchez
MD PhD
Hospital Vall d'Hebron