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NOT YET RECRUITING
NCT07531615
NA

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

Sponsor: Centre Hospitalier Universitaire de Nice

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2026-05-01

Completion Date

2028-07-01

Last Updated

2026-04-15

Healthy Volunteers

No

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 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).

Locations (1)

CHU de Nice

Nice, Alpes-Maritimes, France