跳至主要内容
临床试验/NCT07628205
NCT07628205Enrolling By Invitation2 期

Prehabilitation With Botulinum Toxin A in Complex Hernia: an Italian Prospective Study on Predictive Scores of Myofascial Release.

Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2026年2月17日最近更新:
适应症

试验速览

阶段
2 期
状态
Enrolling By Invitation
发起方
入组人数
44
试验地点
1

研究概览

简要总结

In patients with large hernias, chronic retraction of the lateral abdominal wall muscles, and visceral contents that are irreducible within the hernia sac, closure of the midline can be difficult or even impossible. Component separation techniques (CST), in combination with transversus abdominis release (TAR), increase the flexibility of the abdominal wall and facilitate fascial medialization. However, these techniques alter the anatomy of the abdominal wall and are associated with higher risks of wound complications, abdominal wall disruption, and abdominal compartment syndrome (ACS).

Recently, the preoperative injection of Botulinum Toxin A (BTA) has been proposed as an effective form of chemical component separation of the muscles, or more precisely, chemical relaxation. It has been hypothesized that preoperative chemical paralysis of the lateral abdominal wall muscles through BTA increases abdominal wall compliance and facilitates fascial medialization, thereby reducing the need to resort to CST.

However, the current literature still lacks studies evaluating the impact of BTA on predictive scores for myofascial release and the correlation with intraoperative strategies.

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

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participant is willing and able to give informed consent for participation in the trial
  • Compliance to follow-up
  • Male and female
  • Written informed consent to preoperative BTA injection and/or surgery
  • Age 18 years old
  • Primary ventral hernia
  • Incisional ventral hernia
  • Defect width 10 cm
  • Loss of domain (LoD) 20%

排除标准

  • Medical or psychiatric conditions that compromises the patient's ability to give informed
  • consent or comply with the study protocol
  • Personal reasons
  • Age < 18 years old
  • Defect width < 10 cm
  • LoD < 20%
  • Pregnancy and breastfeeding
  • Allergy/Intolerance to BTA
  • Neuromuscular disorders and diseases
  • Refuse to give informed consent to preoperative BTA injection and/or surgery

研究者

发起方
Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano
申办方类型
Other
责任方
Sponsor

研究点 (1)

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