Ignite Creation Date:
2024-07-17 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499324
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-05-31
Brief Title:
Surgery With Botulinum Toxin A for Incisional Hernia
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Surgical Treatment of Large Incisional Hernia With Botulinum Toxin A Injection a Double-blind Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INCISOX
Brief 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 BTAs 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 BTAs 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
Detailed Description:
Almost 20 of patients will develop an incisional hernia IH after laparotomy Each year in France around 30000 patients undergo IH repair with mesh PMSI 2017 The treatment of large IH width10cm is difficult due to the progressive retraction of the lateral abdominal muscles associated with the separation of the rectus muscles The IH width is a major risk factor of failure of the repair and recurrence Furthermore high rates of severe postoperative morbidity up to 50 have been reported and related to the extent of dissection and increase of muscular tension and abdominal pressure Thus bringing the muscles together to reconstruct the normal anatomy may be impossible and lead the surgeon to use complex and morbid technical procedures such as component separation techniques CST consisting in large aponeurotomy for relaxation of the lateral muscles The intramuscular injection of botulinum toxin A BTA makes it possible to obtain a reversible flaccid paralysis of the striated muscle fibers and its advantage has been demonstrated for the treatment of neurological spasticity Its use to obtain a relaxation of the lateral muscles of the abdomen so-called chemical CST reduce their retraction and facilitate hernia closure as studied in retrospective studies without specific morbidity In particular prehabilitation with BTA injection is supposed to reduce surgical morbidity in comparison with surgical repair and CST The expected clinical benefit in terms of reduction of postoperative morbidity and pain successful closure of the abdomen and reduction of the risk of recurrence of the IH has never been evaluated prospectively Thus a prospective randomized double-blind placebo-controlled trial would be the best method to demonstrate the benefit of BTA injection The investigators hypothesize that BTA injection in the lateral muscles before IH repair is more effective than placebo injection in reducing postoperative morbimortality Secondarily the investigators expect that BTA injection is associated with a significant reduction of complete closure of the abdominal wall without CST
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None