Ovarian Cancer
Conditions
Brief 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.
Interventions
PROCEDUREProphylactic 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.
Application of a PICO negative pressure dressing after skin closure, maintained for 7 days postoperatively.
PROCEDUREStandard 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.
Sponsors
Hospital Vall d'Hebron
Germans Trias i Pujol Hospital
Fundación Jimenez Diaz de Madrid
Hospital Universitario La Fe
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Surgical Site Infection | Within 30 days after surgery | Surgical site infection according to CDC criteria. |
| Incidence of Incisional Hernia at Intermediate Time Points | 3, 6, and 12 months after surgery | Radiologically confirmed incisional hernia detected during routine follow-up imaging. |
| Risk Factors Associated With Incisional Hernia Development | Up to 24 months | Identification of demographic, clinical, oncological, and surgical variables associated with incisional hernia occurrence. |
Countries
Spain
Contacts
CONTACTJose Luis Sánchez Iglesias, MD PhD
Outcome results
None listed