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PROV-MESH: Prophylactic Ovarian Cancer MESH

RecruitingNAAges 18 Years - anyFemaleHospital Vall d'Hebron
NCT07676370 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Prophylactic Mesh Placement
  • Negative Pressure Wound Therapy (NPWT)
  • Standard Fascial Closure
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Where

1 site
Hospital Universitario Vall d'Hebron
Barcelona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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