incisional hernia
Conditions
Brief summary
Occurrence of Clavien-Dindo classification grade II or higher post-operative complication during the 90-day postoperative period.
Detailed description
Length of hospital stay in days, Severity of complication according to the Clavien-Dindo classification during the 90-day postoperative period, Occurrence of CST during IH repair, Occurrence of incomplete wall closure (bridge closure) during IH repair, Sum of the length variation of the left and right lateral muscles (cm), sum of the width variation of the left and right lateral muscles (cm), sum of the width (cm) and surface (cm²) variation of the muscular defect; peritoneal sac volume (cm3) variation, between the pre-inclusion CT and the CT 4 weeks after BTA injection, Intravesical pressure, measured daily until bladder catheter removal, Pain on Analogical Visual Scale at inclusion, from 1st to 7th postoperative day and at 1, 3 (90 days), 6, and 12 months after surgery ; 90-day postoperative prescription of type 3 analgesics, Occurrence of post-operative abdominal wall disruption during a 90 days period after surgery; occurrence of clinical recurrence of the IH during the first year after surgery; occurrence of radiological recurrence of the IH at 12 months post-surgery; 1-year postoperative occurrence of clinical and radiological recurrence of the IH, or reoperation for recurrence;, EQ-5D-5L at inclusion, 90 days, 6, and 12 months after surgery
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of Clavien-Dindo classification grade II or higher post-operative complication during the 90-day postoperative period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Length of hospital stay in days, Severity of complication according to the Clavien-Dindo classification during the 90-day postoperative period, Occurrence of CST during IH repair, Occurrence of incomplete wall closure (bridge closure) during IH repair, Sum of the length variation of the left and right lateral muscles (cm), sum of the width variation of the left and right lateral muscles (cm), sum of the width (cm) and surface (cm²) variation of the muscular defect; peritoneal sac volume (cm3) variation, between the pre-inclusion CT and the CT 4 weeks after BTA injection, Intravesical pressure, measured daily until bladder catheter removal, Pain on Analogical Visual Scale at inclusion, from 1st to 7th postoperative day and at 1, 3 (90 days), 6, and 12 months after surgery ; 90-day postoperative prescription of type 3 analgesics, Occurrence of post-operative abdominal wall disruption during a 90 days period after surgery; occurrence of clinical recurrence of the IH during the first year | — |
Countries
France