PROV-MESH: Prophylactic Ovarian Cancer MESH (PROV-MESH)
2026年6月24日 更新者：Jose Luis Sanchez、Hospital Vall d'Hebron
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
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.
研究概览
地位
招聘中
条件
研究类型
介入性
注册 (估计的)
152
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Jose Luis Sánchez Iglesias, MD PhD
- 电话号码：3217 +34 932746000
- 邮箱：jlsanig@yahoo.es
学习地点
-
-
Barcelona
-
Barcelona、Barcelona、西班牙、08035
- 招聘中
- Hospital Universitario Vall d'Hebron
-
接触：
- Jose Luis Sánchez Iglesias, MD PhD
- 电话号码：3217 +34 932746000
- 邮箱：jlsanig@yahoo.es
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Prophylactic Mesh + Negative Pressure Wound Therapy
Participants will undergo standard fascial closure reinforced with a prophylactic supra-aponeurotic non-absorbable mesh and postoperative negative pressure wound therapy using a PICO dressing for 7 days.
|
Placement of a non-absorbable polypropylene or polyester mesh in a supra-aponeurotic position at the time of abdominal wall closure following cytoreductive surgery.
Application of a PICO negative pressure dressing after skin closure, maintained for 7 days postoperatively.
|
|
实验性的：Prophylactic Mesh without Negative Pressure Wound Therapy
Participants will undergo standard fascial closure reinforced with a prophylactic supra-aponeurotic non-absorbable mesh and standard postoperative wound dressing.
|
Placement of a non-absorbable polypropylene or polyester mesh in a supra-aponeurotic position at the time of abdominal wall closure following cytoreductive surgery.
|
|
有源比较器：Conventional Closure + Negative Pressure Wound Therapy
Participants will undergo standard fascial closure without mesh reinforcement and postoperative negative pressure wound therapy using a PICO dressing for 7 days.
|
Application of a PICO negative pressure dressing after skin closure, maintained for 7 days postoperatively.
Continuous closure of the abdominal fascia using slowly absorbable monofilament suture (PDS 2-0), single-layer closure without peritoneal closure, maintaining a suture-to-wound length ratio greater than 4:1 and employing the small-bites technique.
|
|
实验性的：Conventional Closure without Negative Pressure Wound Therapy
Participants will undergo standard fascial closure without mesh reinforcement and standard postoperative wound dressing.
|
Continuous closure of the abdominal fascia using slowly absorbable monofilament suture (PDS 2-0), single-layer closure without peritoneal closure, maintaining a suture-to-wound length ratio greater than 4:1 and employing the small-bites technique.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of Incisional Hernia
大体时间：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.
|
24 months after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of Surgical Site Infection
大体时间：Within 30 days after surgery
|
Surgical site infection according to CDC criteria.
|
Within 30 days after surgery
|
|
Incidence of Incisional Hernia at Intermediate Time Points
大体时间：3, 6, and 12 months after surgery
|
Radiologically confirmed incisional hernia detected during routine follow-up imaging.
|
3, 6, and 12 months after surgery
|
|
Risk Factors Associated With Incisional Hernia Development
大体时间：Up to 24 months
|
Identification of demographic, clinical, oncological, and surgical variables associated with incisional hernia occurrence.
|
Up to 24 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年1月1日
初级完成 (估计的)
2028年12月31日
研究完成 (估计的)
2030年12月31日
研究注册日期
首次提交
2026年6月24日
首先提交符合 QC 标准的
2026年6月24日
首次发布 (实际的)
2026年6月30日
研究记录更新
最后更新发布 (实际的)
2026年6月30日
上次提交的符合 QC 标准的更新
2026年6月24日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- PI-24-055
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.