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

NCT07531615 | Not Yet Recruiting

• 1 other identifier: 23-AOIP-06
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Hernia Incisional

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Comparison of various technics of abdominal pressure measurement

  After induction, before skin incision and at the end of sur surgery, after skin closure

• Strength to close abdmominal wall

  Before starting abdominal wall closure

Study Arms (1)

Experimental

EXPERIMENTAL

Procedure: Peroperative abdominal pressures measures

Interventions

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).

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, Alpes-Maritimes, 06000, France

Location

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Damien MASSALOU, MD PhD

CONTACT

+33492032264; massalou.d@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 15, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)