PROV-MESH: Prophylactic Ovarian Cancer MESH

Официальное название

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

Обзор

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.

Вмешательства

• Процедура Prophylactic Mesh Placement
  Placement of a non-absorbable polypropylene or polyester mesh in a supra-aponeurotic position at the time of abdominal wall closure following cytoreductive surgery.
• Устройство Negative Pressure Wound Therapy (NPWT)
  Application of a PICO negative pressure dressing after skin closure, maintained for 7 days postoperatively.
• Процедура Standard Fascial Closure
  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.

Первичные конечные точки

• Incidence of Incisional Hernia [Срок оценки: 24 months after surgery]

Вторичные конечные точки (3)

• Incidence of Surgical Site Infection [Срок оценки: Within 30 days after surgery]
• Incidence of Incisional Hernia at Intermediate Time Points [Срок оценки: 3, 6, and 12 months after surgery]
• Risk Factors Associated With Incisional Hernia Development [Срок оценки: Up to 24 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Испания · 1 центр

• Hospital Universitario Vall d'Hebron — Barcelona

Идентификаторы

NCT: NCT07676370 · PI-24-055

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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