Clinical trial · Observational
Ventral Hernias Following Cytoreductive Surgery : Incidence, Risk Factors and Surgical Management.
Incidence, Risk Factors and Surgical Management of Incisional Hernias Following Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy: A Retrospective Monocentric Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cytoreductive Surgery | — | UNRESOLVED | — |
| Ventral Hernias | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Cumulative incidence of post-operative ventral hernias
- timeFrame
- Up to 15 years postoperatively.
- description
- The incidence of adult patients who develop incisonal hernias following cytoreductive surgery ± HIPEC for pseudomyxoma peritonei, colorectal, or ovarian peritoneal carcinomatosis, as documented in the medical records. The incidence of incisional (ventral) hernia following CRS ± HIPEC will be assessed primarily through clinical examination findings documented during follow-up visits. Since some ventral hernias may not be clinically detectable or may remain asymptomatic, imaging studies (CT scan or MRI) performed during routine follow-up will also be used to identify such cases. Imaging reports will be reviewed, and in cases where no report is available, a direct review of the postoperative imaging studies will be conducted to ensure accurate detection of hernias. Ventral hernias occurring at any time during follow-up will be recorded. Only patients with at least 12 months of postoperative follow-up will be included in the analysis.
Secondary outcomes (2)
- measure
- Risk factors for post-operative ventral hernias
- timeFrame
- Up to 15 years postoperatively
- description
- Identification of patient demographics, comorbidities, and surgical variables associated with the development of post-operative ventral hernias. Preoperative risk factors, including baseline demographics, comorbidities, and surgical characteristics, will be assessed at the time of the initial cytoreductive surgery (Day 0). Postoperative risk factors will include: * Early postoperative complications occurring up to 90 days after surgery. * Additional surgical variables, such as the number of subsequent cytoreductive surgeries (repeat laparotomies) following the first CRS. Time to hernia occurrence will be recorded and analyzed using survival models that account for competing risks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available