Surgery With Botulinum Toxin A for Incisional Hernia
NCT Number: NCT06499324
Acronym: INCISOX
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Incisional Hernia
Interventions: DRUG: BTA group|DRUG: Placebo group
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 260
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-11-04
Completion Date: 2029-03-04

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.

Primary Outcome Measures: Demonstrate the efficacy of preoperative BTA injection in the lateral abdominal wall muscles reduces the rate of postoperative morbimortality after large IH (width >= 10cm) repair with mesh, compared with placebo injection., Occurrence of Clavien-Dindo classification grade II or higher post-operative complication, During the 90-day postoperative period
Secondary Outcome Measures: Assessment of the impact of preoperative BTA injection on length of stay., Length of hospital stay in days, From surgery until hospital discharge, average 5 days|Assessment of the impact of preoperative BTA injection on severity of surgical complications, Severity of complications according to the Clavien-Dindo classification, During the 90-day postoperative period|Assessment of the impact of preoperative BTA injection on surgical difficulty: abdominal wall closure with CST; incomplete closure of the wall with need of bridge prosthetic repair, Occurrence of CST and occurrence of incomplete wall closure (bridge closure), During IH repair surgery|Assessment of the impact of preoperative BTA injection on radiological response:lateral muscles elongation, Sum of the length variation of the left and right lateral muscles (cm), Between the pre-inclusion CT-scan and the CT-scan 4 weeks after BTA injection|Assessment of the impact of preoperative BTA injection on radiological response:lateral muscles elongation, Sum of the width variation of the left and right lateral muscles (cm), Between the pre-inclusion CT-scan and the CT-scan 4 weeks after BTA injection|Assessment of the impact of preoperative BTA injection on radiological response: muscular defect reduction, Width (cm) variation of the muscular defect, Between the pre-inclusion CT-scan and the CT-scan 4 weeks after BTA injection|Assessment of the impact of preoperative BTA injection on radiological response: muscular defect reduction, Surface(cm²) variation of the muscular defect, Between the pre-inclusion CT-scan and the CT-scan 4 weeks after BTA injection|Assessment of the impact of preoperative BTA injection on radiological response: hernia sac volume, Volume (cm3) variation of the peritonial sac, Between the pre-inclusion CT-scan and the CT-scan 4 weeks after BTA injection|Assessment of the impact of preoperative BTA injection on intra-abdominal pressure, monitored until bladder catheter removal, Measurement of intravesical pressure, From catheter insertion to removal|Assessment of the impact of preoperative BTA injection on consequences of repair on pain evolution and consumption of analgesics, Pain on Analogical Visual Scale, prescription of type 3 analgesics, From 1st to 7th postoperative day and at 1, 3 , 6, and 12 months after surgery|Assessment of the impact of preoperative BTA injection repair results: post-operative abdominal wall disruption , clinical and radiological recurrence of the IH, Occurrence of post-operative abdominal wall disruption during a 90 days period after surgery, defined as early postoperative abdominal content herniation with or without skin coverage, identified clinically or at CT-scan; Occurrence of clinical recurrence of the IH during the first year after surgery, deﬁned as any fascial defect that was palpable and was located within 7 cm of the site of hernia repair while the patient was in the supine position with legs extended and raised.

Occurrence of radiological recurrence of the IH at 12 months post-surgery; radiologic hernia is defined as any protrusion of abdominal contents including the anterior parietal peritoneum through a discontinuity of the fascial layers on CT performed during follow-up without Valsalva maneuver postoperative occurrence of clinical and radiological recurrence of the IH, or reoperation for recurrence., 90 days and 12 months after surgery|Assessment of the impact of preoperative BTA injection on evolution of quality of life, EQ-5D-5L scale, 90 days, 6, and 12 months after surgery