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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
152
Placement of a non-absorbable polypropylene or polyester mesh in a supra-aponeurotic position at the time of abdominal wall closure following cytoreductive surgery.
Application of a PICO negative pressure dressing after skin closure, maintained for 7 days postoperatively.
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.
Hospital Universitario Vall d'Hebron
Barcelona, Barcelona, Spain
RECRUITINGIncidence of Incisional Hernia
Presence of an abdominal wall incisional hernia confirmed by computed tomography (CT scan) or by imaging performed after clinical suspicion during follow-up.
Time frame: 24 months after surgery
Incidence of Surgical Site Infection
Surgical site infection according to CDC criteria.
Time frame: Within 30 days after surgery
Incidence of Incisional Hernia at Intermediate Time Points
Radiologically confirmed incisional hernia detected during routine follow-up imaging.
Time frame: 3, 6, and 12 months after surgery
Risk Factors Associated With Incisional Hernia Development
Identification of demographic, clinical, oncological, and surgical variables associated with incisional hernia occurrence.
Time frame: Up to 24 months
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