Incisional HerniaNCT03953365
Prophylactic Mesh in Cytoreductive Surgery
A study testing Prophylactic Mesh in people with Incisional Hernia, run by Hospital Universitario Fundación Alcorcón.
Trial summary
Evaluate the effectiveness of mesh reinforcement in high-risk patients to prevent incisional hernia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- Prophylactic Mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completeness of cytoreduction after surgery (CC-SCORE) CC-0, CC-1
Who cannot join
- Completeness of cytoreduction after surgery (CC-SCORE) CC-2, CC-3
About this study
Official title: Prevention of Incisional Hernia With Prophylactic Mesh in Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy. A Multicentre, Prospective, Randomised Controlled Trial
Evaluate the effectiveness of mesh reinforcement in high-risk patients to prevent incisional hernia.
Read the detailed description
Based on the hypothesis that oncological cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC) is associated with an increased risk of developing Incisional Hernia in the postoperative period, with an expected incidence of 50% at 24 months, we designed a prospective, multicenter and randomized clinical study to demonstrate the utility of the meshes in the prevention of Incisional Hernia, hoping to reduce the incidence to 15% at 24 months.
- Conditions
- Incisional Hernia
- Being tested
- Prophylactic Mesh
- Keywords
- hyperthermic intraperitoneal chemotherapy, cytoreduction surgery, prophylactic mesh
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic MeshProcedure or surgery
Prophylactic Mesh after closure of the abdominal wall after Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| without mesh | No intervention | Patients undergo to cytoreductive surgery and hyperthermic intraperitoneal chemotherapy without prophylactic mesh |
| with mesh | Other | Patients undergo to cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with prophylactic mesh Receives: Procedure: Prophylactic Mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Incisional Hernia
Prevention of Incisional Hernia
Measured: four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start1 Jun 2019 (estimated)
- Primary completion31 May 2021 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional HerniaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Fundación Alcorcón
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Ochando, Hospital Universitario Fundación Alcorcón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953365
- Sponsor's protocol ID
- PI 19/41
- Status last verified
- May 2019
- First submitted
- 14 May 2019
- Last updated
- 16 May 2019
- Results posted
- 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 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Incisional Hernia With Prophylactic Mesh in Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy. A Multicentre, Prospective, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03953365
- Acronym / sponsor ID
- PI 19/41
- Conditions
- Incisional Hernia
- Keywords
- hyperthermic intraperitoneal chemotherapy, cytoreduction surgery, prophylactic mesh
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Hospital Universitario Fundación AlcorcónUniversity, hospital or other
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 May 2019 (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.
Evaluate the effectiveness of mesh reinforcement in high-risk patients to prevent incisional hernia.
Detailed description
Based on the hypothesis that oncological cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC) is associated with an increased risk of developing Incisional Hernia in the postoperative period, with an expected incidence of 50% at 24 months, we designed a prospective, multicenter and randomized clinical study to demonstrate the utility of the meshes in the prevention of Incisional Hernia, hoping to reduce the incidence to 15% at 24 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| without mesh | No intervention | –Patients undergo to cytoreductive surgery and hyperthermic intraperitoneal chemotherapy without prophylactic mesh |
| with mesh | Other | Procedure: Prophylactic MeshPatients undergo to cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with prophylactic mesh |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Completeness of cytoreduction after surgery (CC-SCORE) CC-0, CC-1
Key exclusion criteria (1 listed)
- Completeness of cytoreduction after surgery (CC-SCORE) CC-2, CC-3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prophylactic MeshProphylactic Mesh after closure of the abdominal wall after Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy | Procedure or surgery | with mesh |
Primary outcome
Rate of Incisional Hernia
Time frame: four years
Prevention of Incisional Hernia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic Mesh in people with Incisional Hernia, run by Hospital Universitario Fundación Alcorcón.
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 1 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: status not confirmed, as of the sponsor's last update on 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Incisional Hernia (time frame: four years). 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 16 May 2019.