Ventral HerniasNCT07451483
Ventral Hernias Following Cytoreductive Surgery : Incidence, Risk Factors and Surgical Management.
An observational study of Ventral Hernias and Cytoreductive Surgery, run by Jules Bordet Institute at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventral Hernias, Cytoreductive Surgery
- How many people
- 500 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Jan 2026to Mar 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- All adult patients (≥18 years) who underwent CRS +/- HIPEC for PMP, colorectal and ovarian PC between 01 January 2010 and 31 December 2024.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Jules Bordet Institute
Anderlecht, Brussels Capital, 1070
Gabriel Pr. Liberale, MD, Phd, +32 4777606766, gabriele.liberale@hubruxelles.be
About this study
Official title: Incidence, Risk Factors and Surgical Management of Incisional Hernias Following Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy: A Retrospective Monocentric Cohort Study
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.
Read more
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.
- 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
- Medical subject headings
- Hernia, Ventral, Colorectal Neoplasms, Pseudomyxoma Peritonei, Peritoneal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 15 years postoperatively.
Secondary outcomes (2)
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.
Measured: Up to 15 years postoperatively
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.)
Measured: At the time of hernia repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start20 Jan 2026
- Primary completion28 Feb 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Liberale, Jules Bordet Institute
- Investigators
- Gabriel Liberale, MD, Phd, Principal investigator, Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451483
- Sponsor's protocol ID
- CE P2025/425
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Risk Factors and Surgical Management of Incisional Hernias Following Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy: A Retrospective Monocentric Cohort Study
- ClinicalTrials.gov ID
- NCT07451483
- Acronym / sponsor ID
- CE P2025/425
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a retrospective observational study; all data are extracted from historical medical records. No prospective follow-up is conducted.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All adult patients (≥18 years) who underwent CRS +/- HIPEC for PMP, colorectal and ovarian PC between 01 January 2010 and 31 December 2024.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cumulative incidence of post-operative ventral hernias
Time frame: Up to 15 years postoperatively.
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.
2 secondary outcomes
Risk factors for post-operative ventral hernias
Time frame: Up to 15 years postoperatively
Type of surgical technique used for incisional hernia repair
Time frame: At the time of hernia repair
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
Ventral Incisional Hernia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gabriel Liberale, MD, Phd principal investigator
Jules Bordet Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventral Hernias and Cytoreductive Surgery, run by Jules Bordet Institute at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriel Pr. Liberale, MD, PhD (+32 477606766, gabriele.liberale@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of post-operative ventral hernias (time frame: Up to 15 years postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.