Prophylactic mesh during abdominal closure to prevent incisional hernia in ovarian cancer patients
Official title: A Multicenter Randomized Clinical Trial Comparing Prophylactic Mesh Placement Versus Primary Closure, With or Without Negative Pressure Wound Therapy, in Patients Undergoing Primary or Interval Cytoreductive Surgery for Ovarian Cancer
Run by Hospital Vall d'Hebron · NCT07676370 · Data updated 2026-11-12
This trial tests whether placing a prophylactic mesh during abdominal wall closure reduces incisional hernias in women having cytoreductive surgery for ovarian cancer, with an additional randomization to NPWT or standard wound care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 152 (estimated) |
| Sponsor | Hospital Vall d'Hebron Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Barcelona, Barcelona) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2030 |
| Registry record updated | June 30, 2026 |
| Trial ID | NCT07676370 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women with ovarian carcinoma undergoing any form of cytoreductive surgery through a midline laparotomy, able to provide informed consent.
✕Probably not a fit
Patients undergoing recurrent or non-cytoreductive procedures or those not at risk for incisional hernias may derive little to no benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized trial compares prophylactic mesh placement at the time of abdominal wall closure to conventional fascial closure in women undergoing cytoreductive surgery for ovarian cancer via midline laparotomy. To account for wound-care effects, participants are also randomized to receive negative pressure wound therapy (NPWT) or standard wound dressing, creating four arms. The study targets incisional hernia as a key outcome and will monitor surgical site infection and other postoperative events. Eligible patients include women undergoing primary, interval, or post-chemotherapy-delayed cytoreductive surgery, with exclusions for recurrent disease or minimally invasive approaches. Lead sponsorship is from Hospital Vall d'Hebron with several Madrid-area collaborators.
Why it matters
Potential benefit: If successful, prophylactic mesh could lower the risk of incisional hernias and improve long-term quality of life after cytoreductive surgery for ovarian cancer.
How similar studies have gone: Previous studies in other abdominal surgeries have shown potential benefits of prophylactic mesh, but evidence in ovarian cancer cytoreduction is limited and results may vary by setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Hospital Universitario Vall d'Hebron
Barcelona, Barcelona, Spain Recruiting
Study contacts
- Study coordinator: Jose Luis Sánchez Iglesias, MD PhD
- Email: jlsanig@yahoo.es
- Phone: +34 932746000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.