Botulinum Toxin Type A Clinical Trial
Official title:
Botulinum Toxin to Avoid Component Separation in Midline Large Hernias
Introduction. The goal of our study was to compare results in patients with large midline
incisional hernia (LMIH) using only anterior compònent separation (CST) versus preoperative
botulinum toxin (BT) and following Rives repair (RSR).
Material and methods. From to December 2016 to December 2018, a prospective comparative study
was performed in 80 consecutive patients with LMIH and hernia transverse diameter between
12-18 cms at our tertiary center. Two groups were prospectively analyzed: patients underwent
open CST (component separation group or CSG) and patients with preoperative BT administration
and following open RSR (botulinum toxin group or BTG).
Multiple techniques have been described to decrease tension in the closure of the hernia
defect in the large midline incisional hernias (LMIH) (1). Anterior component separation
(CST) has demonstrated to accomplish primary fascial closure, while maintaining normal
anatomy and physiology of the abdominal wall (2,3). However, described limitations of this
technique are complications involving the skin and subcutaneous tissue, most likely caused by
surgical interruption of perforating vessels during exposure of the external oblique muscle.
So, CST has been related to surgical site occurrences (SSO), especially skin necrosis, up to
17% of cases, as well as recurrence rates between 7 and 18% (4).
On the other hand, botulinum toxin type A (BT) has been reported as a therapeutic option to
decrease tension of a fascial closure in LMIH (5). It is a neurotoxin that causes a
reversible denervation and paralisis of the lateral abdominal muscle, and has been considered
as a "chemichal component separation" by some working groups (6). Our long experience about
use of preoperative techniques like BT and progressive pneumperitoneum (PPP) allowed us to
raise the possibility of planning the isolated use of BT in case of long transverse hernia
diameters in patients with LMIH (7).
Taking advantage of the beneficial effect of the neurotoxin, we considered interesting to try
to downstage the CST to other hernia repair with less morbidity, like Rives-Stoppa
retromuscular repair (RSR). This technique has been traditionally considered the gold
standard technique in midline hernias, especially in hernia defects with transverse diameters
around or less than 10 cms, and appears to be more advantageous compared to other surgical
techniques concerning complications and recurrence rates (8). RSR achieves several
objectives: a tension-free closure due to extensive overlap between the prosthesis and the
fascial edges, and the placement of the mesh next to the vascular-rich rectus muscles
facilitates tissue incorporation and minimizing complications related to SSO (9).
The objective of our study was to compare results in two groups of patients with LMIH, using
only CST versus preoperative BT plus following RSR, focusing on the SSO, possibility of
primary fascial closure, length of hospital stay and hernia recurrence rate.
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