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PROV-MESH: Prophylactic Ovarian Cancer MESH

NCT07676370 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2026-06-30

No results posted yet for this study

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.

Conditions

Interventions

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.

DEVICE

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.

Sponsors & Collaborators

  • Germans Trias i Pujol Hospital

    collaborator OTHER

  • Fundación Jimenez Diaz de Madrid

    collaborator UNKNOWN

  • Hospital Universitario La Fe

    collaborator OTHER

  • Hospital Vall d'Hebron

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2028-12-31
Completion
2030-12-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07676370 on ClinicalTrials.gov