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

NCT07451483 | Recruiting

• 1 other identifier: CE P2025/425
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ventral Hernias; Cytoreductive Surgery

Keywords

Ventral Hernias; Cytoreductive Surgery; HIPEC; Surgical Management of Ventral Hernias; Peritoneal Metastasis of Ovarian or Colorectal Cancer, Pseudomyxoma Peritonei; Peritoneal Carcinomatosis

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of post-operative ventral hernias

  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.

  Up to 15 years postoperatively.

Secondary Outcomes (2)

• Risk factors for post-operative ventral hernias

  Up to 15 years postoperatively

• Type of surgical technique used for incisional hernia repair

  At the time of hernia repair

Other Outcomes (1)

• Time interval between cytoreductive surgery and incisional hernia repair

  15 years postoperatively

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This single-center quantitative retrospective study conducted at the Institut Jules Bordet includes patients who underwent cytoreductive surgery ± HIPEC for pseudomyxoma peritonei, colorectal or ovarian peritoneal carcinomatosis between January 1, 2010, and December 31, 2024.

You may qualify if:

• All adult patients (≥18 years) who underwent CRS +/- HIPEC for PMP, colorectal and ovarian PC between 01 January 2010 and 31 December 2024.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (1)

Jules Bordet Institute

Anderlecht, Brussels Capital, 1070, Belgium

RECRUITING

MeSH Terms

Conditions

Hernia, Ventral; Colorectal Neoplasms; Pseudomyxoma Peritonei; Peritoneal Neoplasms

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Adenocarcinoma, Mucinous; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Cystic, Mucinous, and Serous; Abdominal Neoplasms; Peritoneal Diseases

Study Officials

• Gabriel Liberale, MD, Phd

  Jules Bordet Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel Pr. Liberale, MD, PhD

CONTACT

+32 477606766; gabriele.liberale@hubruxelles.be

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: March 5, 2026
• Study Start: January 20, 2026
• Primary Completion: February 28, 2026
• Study Completion: March 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)