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NCT Number: NCT07531615

Assessment of Intra-abdominal Pressure During the Perioperative Period of Hernia Repair

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.

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Key information

Conditions

Hernia Incisional Hernia Incisional Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, Alpes-Maritimes, 06000, France

Location status: Recruiting

Location contact

Damien MASSALOU, MD PhD

CONTACT

[email protected]

+33492032264 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Peroperative abdominal pressures measures

Procedure

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. Strength to close abdmominal wall

    Time frame: Before starting abdominal wall closure

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Damien MASSALOU, MD PhD

CONTACT

[email protected]

+33492032264

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: PRESSEVENT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 15, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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