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
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