PROV-MESH: Prophylactic Ovarian Cancer MESH

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHospital Vall d'Hebron

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

152 Participants
are divided into 4 treatment groups

Locations

1
Hospital Universitario Vall d'Hebron08035, BarcelonaBarcelona, Spain

Sponsors and collaborators

Hospital Vall d'Hebron

Lead sponsor

Germans Trias i Pujol Hospital

Collaborator

Fundación Jimenez Diaz de Madrid

Collaborator

Hospital Universitario La Fe

Collaborator