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Clinical Trials in Belgium / NCT07451483
Recruiting Observational

Ventral Hernias Following Cytoreductive Surgery : Incidence, Risk Factors and Surgical Management.

NCT07451483 · tracked via the Priya Life Science Belgium tracker
Phase
Observational
Started
2026-01-20
Last updated
2026-03-05

Condition(s) studied

Ventral HerniasCytoreductive Surgery

Study summary

Cytoreductive surgery (CRS), with or without hyperthermic intraperitoneal chemotherapy (HIPEC), is currently the standard treatment for advanced peritoneal tumors, including pseudomyxoma peritonei (PMP), colorectal, and ovarian peritoneal carcinomatosis. This complex surgical approach involves extensive resections to remove all visible tumor deposits, often followed by heated intraperitoneal chemotherapy to target residual microscopic disease. While CRS ± HIPEC has been shown to improve survival, it is associated with significant postoperative morbidity, particularly affecting the abdominal wall. One of the most frequent and clinically relevant complications is the development of ventral (incisional) hernias, which can reduce quality of life, limit physical activity, and sometimes require additional surgical repair.

The incidence, risk factors, and optimal management of ventral hernias after CRS ± HIPEC remain incompletely defined. Reported incidences vary widely, likely due to differences in surgical techniques, patient populations, definitions of hernia, and follow-up duration. Known contributing factors include extensive laparotomies, multiple resections, tissue fragility induced by hyperthermic chemotherapy, and patient-specific factors such as age and body mass index. Additionally, management strategies for ventral hernias are heterogeneous, ranging from direct fascial closure to reinforcement with synthetic or biological meshes, using different surgical approaches (onlay or sublay), with limited evidence in oncologic settings.

This single-center retrospective observational study at the Institut Jules Bordet aims to provide a comprehensive analysis of ventral hernia occurrence, risk factors, and management following CRS ± HIPEC. Adult patients who underwent CRS ± HIPEC for PMP, colorectal, or ovarian peritoneal carcinomatosis between January 1, 2010, and December 31, 2024, were included. Patients with prior ventral hernias, incomplete follow-up (\<12 months), missing data, or interrupted CRS due to extensive disease were excluded. Hernias were identified via clinical examination and imaging studies (CT or MRI), and classified as early (\<12 months) or late (\>12 months) postoperative events. Patients were categorized according to the presence or absence of ventral hernias at the incision site.

The primary objective of the study is to determine the incidence of incisional hernias following CRS ± HIPEC. Secondary objectives include (1) identification of patient-related and surgical risk factors associated with hernia development, and (2) analysis of institutional surgical management strategies, including type of repair and timing of intervention. Data were collected retrospectively from medical records, and statistical analyses include descriptive statistics, survival analysis, and univariate and multivariate regression to identify independent risk factors for hernia development.

This study is expected to provide valuable insights into the epidemiology, risk factors, and management of ventral hernias in patients undergoing CRS ± HIPEC, contributing to improved postoperative care, informed surgical planning, and potentially guiding institutional and international recommendations for hernia prevention and repair in this high-risk population.

This study aims to provide a comprehensive understanding of the occurrence, risk factors, and management of ventral hernias in patients undergoing CRS ± HIPEC, which may help guide surgical practice and improve postoperative outcomes.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * All adult patients (≥18 years) who underwent CRS +/- HIPEC for PMP, colorectal and ovarian PC between 01 January 2010 and 31 December 2024. Exclusion Criteria: * Patients with a prior history of ventral hernia at the planned incision site. * Patients undergoing CRS +/- HIPEC for primary cancer other than PMP, colorectal and ovarian PC. * Patients with incomplete medical records preventing data extraction. * Patients lost to follow-up within one year of surgery.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Jules Bordet Institute Anderlecht Brussels Capital Recruiting

More Jules Bordet Institute trials in Belgium

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07451483 on ClinicalTrials.gov ↗ ← All trials in Belgium