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临床试验/NCT04131348
NCT04131348已完成不适用

Botulinum Toxin to Avoid Component Separation in Midline Large Hernias

Hospital Universitario La Fe1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
recurrence rate

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •patients with LMIH with hernia transverse defect between 12 and 18 cms in preoperative CT scan
  • •grade W3 in EHS classification

排除标准

  • •patients with loss of domain hernia (Tanaka index over 20% in CT scan)
  • •laparoscopic approaches
  • •hernias not involving the midline, such as isolated flank and parastomal defects.

研究组 & 干预措施

BTG

Other

patients with preoperative BT administration and following open RSR (botulinum toxin group or BTG).

干预措施: botulinum toxin type A (Procedure)

CSG

Other

patients underwent open CST (component separation group or CSG)

干预措施: botulinum toxin type A (Procedure)

结局指标

主要结局

recurrence rate

时间窗: two years

hernia recurrence rate after surgery in both groups

surgical site ocurrences after hernia repair.

时间窗: two years

focusing on the SSO (seroma, ischemia, infection) after hernia repair in both groups

primary fascial closure

时间窗: two years

possibility of free-tension closure

lenght of stay

时间窗: two years

lenght of hospital stay after hernia repair

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

JOSE BUENO-LLEDÓ

Head of section

Hospital Universitario La Fe

研究点 (1)

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