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Not yet recruiting Not applicable NCT07531615

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

No applicable phase (e.g. observational)
Conditions: Hernia Incisional

Sponsor: Centre Hospitalier Universitaire de Nice

trial.available_in: БГ
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.
Who can participate
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
Interventions
Peroperative abdominal pressures measures
PROCEDURE
Locations 1
France (1)
CHU de Nice
Nice , Alpes-Maritimes
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.05.2026
Completion date
01.07.2028
Registry ID
NCT07531615
Source
clinicaltrials.gov
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