An interventional study of Peroperative abdominal pressures measures in Hernia Incisional, sponsored by Centre Hospitalier Universitaire de Nice. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Other
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.
219 studies on the registry are indexed under Incisional Hernia; 48 are open to participants now.
This study's planned enrollment of 10 is below the median of 108 across 137 interventional studies indexed under Incisional Hernia.
Browse Incisional Hernia studies →Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.
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Exclusion Criteria:
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).
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.
Time frame: After induction, before skin incision and at the end of sur surgery, after skin closure
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.
Time frame: 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.
Time frame: Before starting abdominal wall closure
Plan to share: No
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Centre Hospitalier Universitaire de Nice