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RecruitingNCT07451483Updated Mar 5, 2026

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

An observational study in Ventral Hernias and Cytoreductive Surgery, sponsored by Jules Bordet Institute. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-05.

Sponsored by Jules Bordet Institute · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Jan 2026; still recruiting 9 months later.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
500
Ages
18 Years and older
Sex
All
01

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.

Read the detailed description

This is a retrospective observational study; all data are extracted from historical medical records. No prospective follow-up is conducted.

02

Conditions studied

  • 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
03

In context

Hernia, Ventral

230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.

This study's planned enrollment of 500 is above the median of 132 across 65 observational studies indexed under Hernia, Ventral.

Browse Hernia, Ventral studies →

Lead sponsor

Jules Bordet Institute is the lead sponsor of 106 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
500 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
06

What researchers measure

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.

    Time frame: Up to 15 years postoperatively.

Secondary outcomes

  1. Risk factors for post-operative ventral hernias

    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.

    Time frame: Up to 15 years postoperatively

  2. Type of surgical technique used for incisional hernia repair

    Categorization of surgical management as conservative treatment, biological mesh repair, or synthetic mesh repair. (Analysis of the institutional surgical approaches and outcomes for patients who develop ventral hernias after CRS ± HIPEC, including the surgical technique used (conservative, biological mesh, or synthetic mesh), interval between CRS and hernia repair, postoperative complications, and patient outcomes. Data will be collected retrospectively from medical records.)

    Time frame: At the time of hernia repair

Other outcomes

  1. Time interval between cytoreductive surgery and incisional hernia repair

    Time from initial cytoreductive surgery to surgical repair of incisional hernia.

    Time frame: 15 years postoperatively

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Feb 2026, 1 month after the start.

Of 20 observational studies under Hernia, Ventral, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 72. This study's planned 1 month is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 13, 2026
First posted
Mar 5, 2026
StartActual
Jan 20, 2026
Primary completionEst.
Feb 28, 2026
CompletionEst.
Mar 2026
Last update
Mar 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07451483
Responsible party
Gabriel Liberale (Professor, Jules Bordet Institute) — Principal investigator
First posted
Mar 5, 2026
Start date
Jan 20, 2026
Primary completion
Feb 28, 2026 (estimated)
Completion
Mar 2026 (estimated)
Last update
Mar 5, 2026

Study contacts

Gabriel Pr. Liberale, MD, PhD
Contact
gabriele.liberale@hubruxelles.be
+32 477606766
Gabriel Liberale, MD, Phd
principal investigator · Jules Bordet Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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