Surgical Treatment of Large Incisional Hernia with Botulinum Toxin a Injection: a Double-blind Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

After laparotomy, treating large incisional hernias (width \>= 10cm) proves challenging due to the progressive retraction of lateral abdominal muscles and the separation of rectus muscles. This width is a significant risk factor for repair failure and recurrence. High rates of severe postoperative morbidity, up to 50%, are reported, linked to dissection extent, increased muscular tension, and abdominal pressure. Reconstructing normal anatomy by bringing muscles together may be impossible, leading to the use of complex procedures like component separation techniques (CST), involving large aponeurotomy for muscle relaxation. Intramuscular injection of botulinum toxin A (BTA) induces reversible flaccid paralysis, with potential benefits in hernia closure, known as chemical CST. Retrospective studies suggest reduced muscle retraction and facilitated closure without specific morbidity. Prehabilitation with BTA aims to reduce surgical morbidity compared to repair and CST. The prospective evaluation of BTA's clinical benefits, including reduced postoperative morbidity, pain, successful abdominal closure, and decreased IH recurrence risk, is lacking. A prospective randomized double-blind placebo-controlled trial is proposed to demonstrate BTA's efficacy. The hypothesis is that BTA injection before IH repair is more effective than a placebo in reducing postoperative morbimortality. Secondary expectations include a significant reduction in complete closure of the abdominal wall without CST.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 79
Healthy Volunteers: f
View:

• Patients between 18 and 79 years;

• BMI \< 35 kg/m²;

• Midline anterior primary or recurrent IH (subxiphoidal to suprapubic), of width \>= 10 cm, on the abdominopelvic CT without injection of contrast agent, performed in the 6 months before inclusion (EHS W3);

• IH without loss of domain, defined by the ratio: (volume of the peritoneal sac) / (total peritoneal volume) \< 25%, on the abdominal CT without injection of contrast agent, performed in the 6 months before inclusion;

• Written informed consent;

• Scheduled surgery for an open IH repair;

• For female of childbearing potential: using highly effective contraception.

Locations
Other Locations
France
David Moszkowicz
RECRUITING
Colombes
Contact Information
Primary
David MOSZKOWICZ, MD-PhD
david.moszkowicz@aphp.fr
+33 (0)1 47 60 66 02
Time Frame
Start Date: 2025-01-17
Estimated Completion Date: 2029-03-04
Participants
Target number of participants: 260
Treatments
Experimental: BTA group
This arm corresponds to patients presenting with midline anterior primary or recurrent IH (subxiphoidal to suprapubic) of width \>= 10 cm, without loss of domain, scheduled for IH repair with mesh.~Patients will be injected with 288 IU of BTA (XEOMIN® 100U) into the lateral muscles (18 injection sites, 16UI/8mL/injection site), 4 to 6 weeks before the treatment of the IH.
Placebo_comparator: Placebo group
This arm corresponds to patients presenting with midline anterior primary or recurrent IH (subxiphoidal to suprapubic) of width \>= 10 cm, without loss of domain, scheduled for IH repair with mesh.~Patients will be injected with placebo of BTA (XEOMIN® 100U matching placebo) into the lateral muscles (18 injection sites, 8mL/injection site), 4 to 6 weeks before the treatment of the IH.
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov