PROV-MESH: Prophylactic Ovarian Cancer MESH

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Negative Pressure Wound Therapy (NPWT): Application of a PICO negative pressure dressing after skin closure, maintained for 7 days postoperatively.

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Incidence of Incisional Hernia — 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.

Trial sites (1)

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