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Surgical treatment of large incisional hernia with botulinum toxin A injection: a double-blind randomized controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504554-35-00
Acronym
APHP220805
Enrollment
260
Registered
2024-04-29
Start date
2025-01-17
Completion date
Unknown
Last updated
2025-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

incisional hernia

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

DRUGPlacebo of XEOMIN 100UY
DRUGpoudre pour solution injectable

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Occurrence of Clavien-Dindo classification grade II or higher post-operative complication during the 90-day postoperative period.

Secondary

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026