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

Overview

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.

Interventions

• 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 marke

Primary outcome measures

• Abdominal pressure measures [Time frame: After induction, before skin incision and at the end of sur surgery, after skin closure]

Secondary outcome measures (2)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

France · 1 center

• CHU de Nice — Nice

Identifiers

NCT: NCT07531615 · 23-AOIP-06

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗