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PROV-MESH: Prophylactic Ovarian Cancer MESH (PROV-MESH)

24. juni 2026 opdateret af: Jose Luis Sanchez, Hospital Vall d'Hebron

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

152

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Jose Luis Sánchez Iglesias, MD PhD
  • Telefonnummer: 3217 +34 932746000
  • E-mail: jlsanig@yahoo.es

Studiesteder

  • Spanien
    • Barcelona
      • Barcelona, Barcelona, Spanien, 08035
        • Rekruttering
        • Hospital Universitario Vall d'Hebron
        • Kontakt:
          • Jose Luis Sánchez Iglesias, MD PhD
          • Telefonnummer: 3217 +34 932746000
          • E-mail: jlsanig@yahoo.es

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Prophylactic Mesh + Negative Pressure Wound Therapy
Participants will undergo standard fascial closure reinforced with a prophylactic supra-aponeurotic non-absorbable mesh and postoperative negative pressure wound therapy using a PICO dressing for 7 days.
Procedure: Prophylactic 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.
Enhed: Negative Pressure Wound Therapy (NPWT)
Application of a PICO negative pressure dressing after skin closure, maintained for 7 days postoperatively.
Eksperimentel: Prophylactic Mesh without Negative Pressure Wound Therapy
Participants will undergo standard fascial closure reinforced with a prophylactic supra-aponeurotic non-absorbable mesh and standard postoperative wound dressing.
Procedure: Prophylactic 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.
Aktiv komparator: Conventional Closure + Negative Pressure Wound Therapy
Participants will undergo standard fascial closure without mesh reinforcement and postoperative negative pressure wound therapy using a PICO dressing for 7 days.
Enhed: Negative Pressure Wound Therapy (NPWT)
Application of a PICO negative pressure dressing after skin closure, maintained for 7 days postoperatively.
Procedure: Standard 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.
Eksperimentel: Conventional Closure without Negative Pressure Wound Therapy
Participants will undergo standard fascial closure without mesh reinforcement and standard postoperative wound dressing.
Procedure: Standard 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Incisional Hernia
Tidsramme: 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.
24 months after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Surgical Site Infection
Tidsramme: Within 30 days after surgery
Surgical site infection according to CDC criteria.
Within 30 days after surgery
Incidence of Incisional Hernia at Intermediate Time Points
Tidsramme: 3, 6, and 12 months after surgery
Radiologically confirmed incisional hernia detected during routine follow-up imaging.
3, 6, and 12 months after surgery
Risk Factors Associated With Incisional Hernia Development
Tidsramme: Up to 24 months
Identification of demographic, clinical, oncological, and surgical variables associated with incisional hernia occurrence.
Up to 24 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hospital Vall d'Hebron

Samarbejdspartnere

Germans Trias i Pujol Hospital
Hospital Universitario La Fe
Fundación Jimenez Diaz de Madrid

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2026

Primær færdiggørelse (Anslået)

31. december 2028

Studieafslutning (Anslået)

31. december 2030

Datoer for studieregistrering

Først indsendt

24. juni 2026

Først indsendt, der opfyldte QC-kriterier

24. juni 2026

Først opslået (Faktiske)

30. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PI-24-055

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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