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

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 Overview

• Status: Not yet recruiting
• Conditions: Hernia Incisional
• Intervention / Treatment: Procedure: Peroperative abdominal pressures measures

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Damien MASSALOU, MD PhD; Phone Number: +33492032264; Email: massalou.d@chu-nice.fr

Study Locations

• France
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06000
      • Chu de Nice
      • Contact: Damien MASSALOU, MD PhD; Phone Number: +33 +33492032264; Email: massalou.d@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental

Procedure: Peroperative abdominal pressures measures; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After induction, before skin incision and at the end of sur surgery, after skin closure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Before starting abdominal wall closure

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Pathological Conditions, Anatomical; Hernia; Pathological Conditions, Signs and Symptoms; Incisional Hernia
• Other Study ID Numbers: 23-AOIP-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No