Hernia Incisional
Conditions
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.
Interventions
PROCEDUREPeroperative 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).
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal pressure measures | After induction, before skin incision and at the end of sur surgery, after skin closure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Strength to close abdmominal wall | Before starting abdominal wall closure | 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. |
| Comparison of various technics of abdominal pressure measurement | After induction, before skin incision and at the end of sur surgery, after skin closure | 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. |
Countries
France
Contacts
CONTACTDamien MASSALOU, MD PhD
Outcome results
None listed