PROV-MESH: Prophylactic Ovarian Cancer MESH
ConditionOvarian Cancer
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Factorial
Treatments tested in this trial
Prophylactic Mesh Placement
Procedure/SurgeryPlacement 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)
DeviceApplication of a PICO negative pressure dressing after skin closure, maintained for 7 days postoperatively.
Standard Fascial Closure
Procedure/SurgeryContinuous 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.
Treatment groups
152 Participants
are divided into 4 treatment groupsGroup A: Prophylactic Mesh + Negative Pressure Wound TherapyExperimental treatment 2 interventions
Group B: Prophylactic Mesh without Negative Pressure Wound TherapyExperimental treatment 1 intervention
Group C: Conventional Closure + Negative Pressure Wound TherapyActive comparator 2 interventions
Group D: Conventional Closure without Negative Pressure Wound TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence 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 surgerySecondary outcomes
1
Incidence of Surgical Site Infection
Surgical site infection according to CDC criteria.
Time frame
Within 30 days after surgery2
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 surgery3
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital Vall d'Hebron
Lead sponsor
Germans Trias i Pujol Hospital
Collaborator
Fundación Jimenez Diaz de Madrid
Collaborator
Hospital Universitario La Fe
Collaborator
Source ClinicalTrials.gov