跳至主要内容
临床试验/NCT07349628
NCT07349628已完成不适用

Preoperative Botulinum Toxin A Enables Fascial Closure and Reduces Morbidity in Complex Incisional Hernias: Results From the Prospective

Azienda Sanitaria Locale Napoli 2 Nord0 个研究点目标入组 32 人开始时间: 2021年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32

研究概览

简要总结

Brief Study Description

This prospective observational study evaluates the use of preoperative botulinum toxin A as part of a structured clinical pathway for patients undergoing elective repair of complex midline incisional hernias. Botulinum toxin A is administered before surgery to temporarily relax the abdominal wall muscles, with the aim of improving abdominal wall flexibility and facilitating closure of the hernia without the need for more extensive surgical techniques. The study collects clinical, radiological, and postoperative outcome data to assess surgical feasibility, complications, and early recurrence. The overall goal is to better understand how preoperative muscle relaxation may support safer and more effective abdominal wall reconstruction.

详细描述

Detailed Description

This prospective observational study investigates a preoperative strategy designed to improve surgical outcomes in patients with complex midline incisional hernias. These hernias often involve large abdominal wall defects and significant muscle retraction, which can make surgical repair difficult and increase the risk of complications. To address these challenges, the study evaluates the use of botulinum toxin A administered before surgery as part of a standardized clinical pathway known as the BRIDGE-HERNIA protocol.

Botulinum toxin A is injected into the lateral abdominal wall muscles several weeks before the planned operation. Its temporary muscle-relaxing effect increases the flexibility of the abdominal wall, which may allow surgeons to close the hernia defect more easily and avoid more invasive surgical techniques. All patients undergo detailed preoperative assessment, including imaging studies, to evaluate abdominal wall anatomy and to plan the surgical approach. After botulinum toxin administration, imaging is repeated to assess changes in muscle length and hernia dimensions.

The study prospectively collects clinical, radiological, surgical, and postoperative data. Primary outcomes include the feasibility of achieving direct fascial closure without advanced component separation techniques. Secondary outcomes include postoperative complications, length of hospital stay, early hernia recurrence, and patient-reported quality of life. Because the study is observational, all treatments are delivered according to routine clinical practice, and no additional experimental interventions are assigned by the study protocol.

The results of this study aim to improve understanding of how preoperative muscle relaxation can support safer and less invasive surgical repair of complex incisional hernias, and to provide evidence that may help optimize surgical planning and patient selection in abdominal wall reconstruction.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Age 18 years or older
  • Diagnosis of complex midline incisional hernia
  • Planned elective surgical repair of the incisional hernia
  • Preoperative management including botulinum toxin A administration as part of routine clinical care
  • Ability to undergo contrast-enhanced computed tomography imaging
  • Ability to provide written informed consent

排除标准

  • 未提供

研究者

发起方
Azienda Sanitaria Locale Napoli 2 Nord
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesco Pizza

Principal Investigator,

Azienda Sanitaria Locale Napoli 2 Nord

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