Hernia IncisionalPRESSEVENTNCT07531615
Assessment of Intra-abdominal Pressure During the Perioperative Period of Hernia Repair
A study testing Peroperative abdominal pressures measures in people with Hernia Incisional, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Thousands of patients worldwide undergo abdominal surgery every day; 2-11% of laparotomies will progress to an incisional hernia, particularly midline laparotomies, which are associated with higher hernia rates, reaching up to 70% in obese patients (1,2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia Incisional
- What is being tested?
- Peroperative abdominal pressures measures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jul 2026to 1 Aug 2028
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Midline incisional hernias with a hernia defect width between 4 and 10 cm in the transverse axis, corresponding to W2 according to the EHS classification
- M2, M3, and M4 locations according to the EHS classification (i.e., hernia defects located from 3 cm below the xiphoid process to 3 cm above the upper border of the pubic symphysis)
- Patients scheduled for elective open midline incisional hernia repair with retromuscular mesh placement
- Provision of written informed consent
- Affiliation with a national health insurance system
Who cannot join
- Other types of incisional hernia
- Minimally invasive surgery (laparoscopic or robotic approach)
- Patients under legal protection (guardianship or curatorship), or patients unable to participate in a clinical study in accordance with Article L.1121-16 of the French Public Health Code
- Pregnant or breastfeeding women of childbearing age
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nice
Nice, Alpes-Maritimes, 06000
Damien MASSALOU, MD PhD, +33492032264 ext. +33, massalou.d@chu-nice.fr
About this study
Thousands of patients worldwide undergo abdominal surgery every day; 2-11% of laparotomies will progress to an incisional hernia, particularly midline laparotomies, which are associated with higher hernia rates, reaching up to 70% in obese patients (1,2). Long-term recurrence after incisional hernia repair is close to 30% after primary repair and may increase to 70% in cases of iterative (redo) surgery (3).
The main risk factors for incisional hernia formation or recurrence include surgical site infection, surgical technique, respiratory insufficiency (COPD), as well as overweight and obesity, the prevalence of which is rapidly increasing.
Read more
Midline incisional hernias are the most frequent and represent a significant public health issue.
In abdominal wall surgery, some teams perform so-called tension-free repairs, whereas others favor repairs under tension. The tension-free concept may be associated with a lower recurrence rate. However, this intuitive concept has never been mechanically defined, using perioperative pressure measurements or surface tension assessment. Few studies have investigated abdominal pressure and muscle tension measurements in relation to abdominal wall surgery.
The aim of this study is to evaluate a protocol for measuring abdominal pressures during open repair of midline incisional hernia.
- Conditions
- Hernia Incisional
- Being tested
- Peroperative abdominal pressures measures
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peroperative abdominal pressures measuresProcedure or surgery
Muscle pressure will be monitored peroperatively as follows:
- Following the TAP block performed by the anesthesiology team after anesthetic induction, measurements will be obtained in the transversus abdominis muscles, bilaterally, at the midpoint between the upper border of the iliac crest and the lower costal margin.
- An additional measurement within the rectus sheath will be performed 3 cm lateral to the umbilicus, on both sides.
- Measurement sites will be marked on the skin using a marker.
- A urinary catheter will be inserted, and intra-vesical pressure will be measured after induction of anesthesia.
Muscle and intra-vesical pressure monitoring will be repeated after completion of incisional hernia repair with retro-muscular mesh placement and complete abdominal wall closure, at the same anatomical locations.
Dynamometer measurements will be performed after completion of the dissection and before fascial closure (suture repair prior to mesh placement).
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Procedure: Peroperative abdominal pressures measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal pressure measures
The intraoperative increase in vesical and muscular pressures will be assessed by measuring pressure within the transversus abdominis muscles and the rectus sheath, bilaterally, as well as intravesical pressure.
Measured: After induction, before skin incision and at the end of sur surgery, after skin closure
Secondary outcomes (2)
Comparison of various technics of abdominal pressure measurement
Parietal muscular and vesical pressures will be compared preoperatively and postoperatively, with an expected increase in intraperitoneal and abdominal wall pressures at the end of the procedure. Data will be collected and subsequently subjected to statistical analysis. As this is a pilot study with a small sample size, statistically significant results may not be achieved.
Measured: After induction, before skin incision and at the end of sur surgery, after skin closure
Strength to close abdmominal wall
Intraoperative dynamometer-measured pressure will be recorded. The investigators will document the force required to approximate the two edges of the incisional hernia at the midline (corresponding to the linea alba), both for posterior rectus sheath closure and anterior rectus sheath closure. Data will be collected and subsequently analyzed statistically. As this is a pilot study with a limited sample size, statistically significant results may not be obtained.
Measured: Before starting abdominal wall closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start30 Jul 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia IncisionalStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531615
- Sponsor's protocol ID
- 23-AOIP-06
- Acronym
- PRESSEVENT
- Status last verified
- Jul 2026
- First submitted
- 8 Apr 2026
- Last updated
- 2 Jul 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 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Intra-abdominal Pressure During the Perioperative Period of Hernia Repair
- ClinicalTrials.gov ID
- NCT07531615
- Acronym / sponsor ID
- PRESSEVENT / 23-AOIP-06
- Conditions
- Hernia Incisional
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 15 Apr 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.
Thousands of patients worldwide undergo abdominal surgery every day; 2-11% of laparotomies will progress to an incisional hernia, particularly midline laparotomies, which are associated with higher hernia rates, reaching up to 70% in obese patients (1,2). Long-term recurrence after incisional hernia repair is close to 30% after primary repair and may increase to 70% in cases of iterative (redo) surgery (3).
The main risk factors for incisional hernia formation or recurrence include surgical site infection, surgical technique, respiratory insufficiency (COPD), as well as overweight and obesity, the prevalence of which is rapidly increasing.
Midline incisional hernias are the most frequent and represent a significant public health issue.
In abdominal wall surgery, some teams perform so-called tension-free repairs, whereas others favor repairs under tension. The tension-free concept may be associated with a lower recurrence rate. However, this intuitive concept has never been mechanically defined, using perioperative pressure measurements or surface tension assessment. Few studies have investigated abdominal pressure and muscle tension measurements in relation to abdominal wall surgery.
The aim of this study is to evaluate a protocol for measuring abdominal pressures during open repair of midline incisional hernia.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: Peroperative abdominal pressures measures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Midline incisional hernias with a hernia defect width between 4 and 10 cm in the transverse axis, corresponding to W2 according to the EHS classification
- M2, M3, and M4 locations according to the EHS classification (i.e., hernia defects located from 3 cm below the xiphoid process to 3 cm above the upper border of the pubic symphysis)
- Patients scheduled for elective open midline incisional hernia repair with retromuscular mesh placement
- Provision of written informed consent
- Affiliation with a national health insurance system
Key exclusion criteria (4 listed)
- Other types of incisional hernia
- Minimally invasive surgery (laparoscopic or robotic approach)
- Patients under legal protection (guardianship or curatorship), or patients unable to participate in a clinical study in accordance with Article L.1121-16 of the French Public Health Code
- Pregnant or breastfeeding women of childbearing age
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 |
|---|---|---|
| Peroperative abdominal pressures measuresMuscle pressure will be monitored peroperatively as follows: * Following the TAP block performed by the anesthesiology team after anesthetic induction, measurements will be obtained in the transversus abdominis muscles, bilaterally, at the midpoint between the upper border of the iliac crest and the lower costal margin. * An additional measurement within the rectus sheath will be performed 3 cm lateral to the umbilicus, on both sides. * Measurement sites will be marked on the skin using a marker. * A urinary catheter will be inserted, and intra-vesical pressure will be measured after induction of anesthesia. Muscle and intra-vesical pressure monitoring will be repeated after completion of incisional hernia repair with retro-muscular mesh placement and complete abdominal wall closure, at the same anatomical locations. Dynamometer measurements will be performed after completion of the dissection and before fascial closure (suture repair prior to mesh placement). | Procedure or surgery | Experimental |
Primary outcome
Abdominal pressure measures
Time frame: After induction, before skin incision and at the end of sur surgery, after skin closure
The intraoperative increase in vesical and muscular pressures will be assessed by measuring pressure within the transversus abdominis muscles and the rectus sheath, bilaterally, as well as intravesical pressure.
2 secondary outcomes
Comparison of various technics of abdominal pressure measurement
Time frame: After induction, before skin incision and at the end of sur surgery, after skin closure
Strength to close abdmominal wall
Time frame: Before starting abdominal wall closure
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 2 Jul 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peroperative abdominal pressures measures in people with Hernia Incisional, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 5 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 2 Jul 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 France. 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 Damien MASSALOU, MD PhD (+33492032264, massalou.d@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal pressure measures (time frame: After induction, before skin incision and at the end of sur surgery, after skin closure). 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 2 Jul 2026.