Incisional HerniaPhase 4PSHERNIANCT03495557
Prevalence of Port Site Hernia After Mesh Placement in Laparoscopic Cholecystectomy.
A Phase 4 study testing Experimental in people with Incisional Hernia, run by Hospital de Mataró at 1 site in Spain.
Trial summary
A prophylactic mesh fixation after fascial closure in umbilical trocar after cholecystectomy may prevent the trocar site hernia incidence. Especially in patients who present certain risk factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- Experimental
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2018to 1 Sep 2021
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Laparoscopic cholecystectomy
- Emergent/elective
- ≥2 risk factors: diabetes mellitus, age ≥70 years, BMI ≥30, fascial enlargement
Who cannot join
- Conversion to laparotomy
- Emergent re intervention
- Immunosuppression
- Umbilical hernia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Port Site Hernia Prevalence After Prophylactic Mesh Placement Following Laparoscopic Cholecystectomy: Randomized Clinical Trial
A prophylactic mesh fixation after fascial closure in umbilical trocar after cholecystectomy may prevent the trocar site hernia incidence. Especially in patients who present certain risk factors.
Read the detailed description
Randomized controlled trial. Patients with more than two incisional hernia risk factors (age ≥70, BMI ≥30, diabetes mellitus, fascial enlargement) who undergo elective/emergent cholecystectomy. Control arm: fascial closure with simple PDS 2/0 Stitches. Study arm: fascial closure with simple PDS 2/0 stitches and onlay polypropylene mesh placement. Main outcome umbilical trocar site hernia incidence during a 3 years follow up. Clinical and radiological assessment.
- Conditions
- Incisional Hernia
- Being tested
- Control, Experimental
- Keywords
- Hernia, Cholecystectomy, Mesh fixation
- Medical subject headings
- Incisional Hernia, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlProcedure or surgery
Fascial closure with simple polydioxanone suture 2/0 stitches
ExperimentalDevice
Onlay polypropylene mesh placement (MN mesh)
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Simple closure Receives: Procedure: Control |
| Experimental | Experimental | Simple closure + mesh Receives: Device: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Umbilical trocar site hernia incidence
Umbilical trocar site hernia incidence after 6 months and 1 year (clinical assessment) and after 3 years (radiological confirmation)
Measured: 3 years
Secondary outcomes (9)
Seroma incidence
A mass or tumefaction caused by the localized accumulation of serum within the tissue (clinical assessment)
Measured: 6 months
Hematoma incidence
A localized collection of extravasated blood clotted under the tissue (clinical assessment)
Measured: 6 months
Wound infection incidence
Combination of redness, swelling, warm and/or fluid drainage in the wound assessed clinically
Measured: 6 months
Pain presence
Pain presence related to the umbilical wound scored from 0 (no pain) to 10 (severe pain)
Measured: 6 months, 1 and 3 years
Hospital discharge
When patients leave the hospital after the intervention, measured by hours
Measured: 48 hours
Operative time
Intervention duration, measured by minutes
Measured: 2 hours
Return to regular activity
When patient return to job or regular activities after surgery, measured by days
Measured: 6 months
Patient satisfaction
How satisfied/unsatisfied is the patient with the whole process measured by a survey form which classify it in a range from 0 (very unsatisfied) to 5 (very satisfied)
Measured: 3 years
Surgeon satisfaction
How satisfied/unsatisfied is the surgeon with the whole process measured by a survey form which classify it in a range from 0 (very unsatisfied) to 5 (very satisfied)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start1 Jan 2018
- Primary completion1 Dec 2020
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control will have simple closure while experimental group will have simple closure+mesh
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Mataró
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Ciscar, Hospital de Mataró
- Investigators
- Ana Ciscar, MD, Principal investigator, Hospital de Mataró
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495557
- Sponsor's protocol ID
- PORT SITE HERNIA
- Acronym
- PSHERNIA
- Status last verified
- Mar 2022
- First submitted
- 23 Mar 2018
- Last updated
- 23 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ciscar A, Sanchez-Saez E, Vila Tura M, Ruiz de Leon P, Gomez Pallares M, Troyano Escribano D, Abadal Prades M, Mans Muntwyler E, Pereira JA, Badia JM. Assessment of the effectiveness of a polypropylene onlay mesh in the prevention of laparoscopic trocar-site incisional hernia in high-risk patients. A randomized clinical trial. Hernia. 2024 Dec;28(6):2187-2194. doi: 10.1007/s10029-024-03124-7. Epub 2024 Aug 29.
PubMed 39207550
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Port Site Hernia Prevalence After Prophylactic Mesh Placement Following Laparoscopic Cholecystectomy: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03495557
- Acronym / sponsor ID
- PSHERNIA / PORT SITE HERNIA
- Conditions
- Incisional Hernia
- Keywords
- Hernia, Cholecystectomy, Mesh fixation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hospital de MataróUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 12 Apr 2018 (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.
A prophylactic mesh fixation after fascial closure in umbilical trocar after cholecystectomy may prevent the trocar site hernia incidence. Especially in patients who present certain risk factors.
Detailed description
Randomized controlled trial. Patients with more than two incisional hernia risk factors (age ≥70, BMI ≥30, diabetes mellitus, fascial enlargement) who undergo elective/emergent cholecystectomy. Control arm: fascial closure with simple PDS 2/0 Stitches. Study arm: fascial closure with simple PDS 2/0 stitches and onlay polypropylene mesh placement. Main outcome umbilical trocar site hernia incidence during a 3 years follow up. Clinical and radiological assessment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Control will have simple closure while experimental group will have simple closure+mesh
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Procedure: ControlSimple closure |
| Experimental | Experimental | Device: ExperimentalSimple closure + mesh |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Laparoscopic cholecystectomy
- Emergent/elective
- ≥2 risk factors: diabetes mellitus, age ≥70 years, BMI ≥30, fascial enlargement
Key exclusion criteria (4 listed)
- Conversion to laparotomy
- Emergent re intervention
- Immunosuppression
- Umbilical hernia
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 |
|---|---|---|
| ControlFascial closure with simple polydioxanone suture 2/0 stitches | Procedure or surgery | Control |
| ExperimentalOnlay polypropylene mesh placement (MN mesh) | Device | Experimental |
Primary outcome
Umbilical trocar site hernia incidence
Time frame: 3 years
Umbilical trocar site hernia incidence after 6 months and 1 year (clinical assessment) and after 3 years (radiological confirmation)
9 secondary outcomes
Seroma incidence
Time frame: 6 months
Hematoma incidence
Time frame: 6 months
Wound infection incidence
Time frame: 6 months
Pain presence
Time frame: 6 months, 1 and 3 years
Hospital discharge
Time frame: 48 hours
Operative time
Time frame: 2 hours
Return to regular activity
Time frame: 6 months
Patient satisfaction
Time frame: 3 years
Surgeon satisfaction
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Derived from this study: PubMed 39207550Ciscar A, Sanchez-Saez E, Vila Tura M, Ruiz de Leon P, Gomez Pallares M, Troyano Escribano D, Abadal Prades M, Mans Muntwyler E, Pereira JA, Badia JM. Assessment of the effectiveness of a polypropylene onlay mesh in the prevention of laparoscopic trocar-site incisional hernia in high-risk patients. A randomized clinical trial. Hernia. 2024 Dec;28(6):2187-2194. doi: 10.1007/s10029-024-03124-7. Epub 2024 Aug 29.
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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.
Ana Ciscar, MD principal investigator
Hospital de Mataró
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Experimental in people with Incisional Hernia, run by Hospital de Mataró at 1 site in Spain.
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 4 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: finished, as of the sponsor's last update on 23 Mar 2022. 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 Spain. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Umbilical trocar site hernia incidence (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03495557, which also lists 1 linked publication.
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 23 Mar 2022; AzTrials last refreshed its copy on 7 Nov 2026.