P-077 SURGICAL TREATMENT OF LARGE INCISIONAL HERNIA WITH BOTULINUM TOXIN A INJECTION: STUDY PROTOCOL FOR A DOUBLE-BLIND RANDOMIZED CONTROLLED TRIAL

Abstract

Abstract Aim The best strategy for W3 incisional hernia (IH) repair is not known to date and is associated with high risks of recurrence and morbidity. We aim to demonstrate that preoperative Botulinum Toxin A (BTA) injection in the lateral abdominal wall muscles reduces the rate of postoperative morbimortality after large IH (EHS W3) repair with mesh, compared with placebo injection. Material & Methods This study will be a prospective, national multi-center, double-blinded, randomized (1:1) superiority phase III trial with two parallel arms: BTA versus placebo injection. Participants will be selected based on an abdomino-pelvic CT-scan without contrast injection performed in the 6 months preceding the patient's surgery. Main inclusion criteria will comprise midline anterior primary or recurrent IH (subxiphoidal to suprapubic), of width ≥ 10 cm, without loss of domain. Patients included will be randomized (1: 1 ratio), by using a computer-generated randomization scheme, and randomization will by stratified on the center and width of the IH (10–15 cm and > 15 cm). Participants will be randomized on the day of the injection, at least 4 weeks before the surgery. Results The primary endpoint will be the occurrence of Clavien-Dindo classification grade II or higher post-operative complication during the 90-day postoperative period. Secondary endpoints will include the rates of primary fascial closure, occurrence of component separation techniques, radiological response to injections, consumption of analgesics and pain, and occurrence of clinical and radiological recurrences. Conclusions Protocol version 2.0 is currently being assessed for funding by the French Ministry of Health.