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临床试验/NCT06485440
NCT06485440已完成不适用

The Effects of Preoperative Botulinum Toxin A Injection Prior to Abdominal Wall Reconstruction Procedures on Respiratory System Function

Swissmed Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
PEF (peak expiratory flow)

研究概览

简要总结

Hernias are common complications post-abdominal surgeries, often leading to significant issues such as "loss of domain," where organs shift permanently, reducing abdominal cavity capacity. This complicates surgeries as there is insufficient space to reposition organs. A growing method to address this involves preoperative botulinum toxin A (BTA) injections into lateral abdominal muscles. BTA induces temporary paralysis, expanding the abdominal cavity and aiding muscle approximation for hernia repair. Initiated in 2009, this approach is particularly used for defects over 10cm. However, standardized protocols are lacking, and the impact on respiratory function remains under-researched. This study aims to evaluate the effects of preoperative BTA injections on respiratory volumes. Ten patients will undergo pulmonary function tests before and after BTA injections. The study will focus on changes in respiratory efficiency, given the respiratory challenges associated with large hernias and the "loss of domain" effect.

详细描述

Hernias are frequent complications following abdominal procedures, particularly in cases of large defects which may lead to the "loss of domain" effect. This phenomenon involves permanent displacement of organs into an alternative space, reducing the effective capacity of the peritoneal cavity. Surgical management of giant hernial sacs is challenging due to insufficient space within the abdominal cavity to accommodate organ repositioning.

Abdominal wall reconstruction specialists have developed various techniques to address these complexities. One increasingly utilized method involves the injection of botulinum toxin A (BTA) into the lateral abdominal muscles (external oblique, internal oblique, and transverse muscles). BTA induces temporary muscular paralysis lasting approximately 6-8 months. This paralysis extends the muscle compartment, thereby increasing abdominal cavity volume. This expansion facilitates the approximation of rectus abdominis muscles and the closure of fascial defects.

Initial attempts to employ BTA for the treatment of giant abdominal hernias began in 2009. Since then, its role in abdominal wall surgery has grown steadily. Optimal timing for surgery post-BTA injection is typically 3-4 weeks, when maximal muscle extension and abdominal volume increase (up to 20-30%) are observed.

Despite widespread clinical use, standardized protocols for BTA application remain lacking due to limited comparative studies and small sample sizes in existing literature. Rare allergic reactions aside, comprehensive documentation of adverse effects from BTA injections remains minimal. However, variability in patient response suggests potential differences in treatment efficacy.

Respiratory efficiency poses a significant challenge in patients with giant abdominal hernias, exacerbated by the "loss of domain" effect which impairs diaphragm function and alters respiratory mechanics. Predicting perioperative outcomes is further complicated by advanced age, comorbidities, and obesity among affected patients.

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

  • Large abdominal hernia (at least W3 in the EHS classification), requiring additional preoperative techniques to prevent ACS (abdominal compartment syndrome) in the postoperative period.
  • Age >18 years.
  • Written consent to participate in the study.
  • Health status allowing the safe conduct of surgery.

排除标准

  • 1. Refusal to participate in the study.

研究组 & 干预措施

BTA

10 patients with giant hernias of the anterior abdominal wall (W3 in the classification of the European Hernia Society) prepared with BTA injections prior to surgery

干预措施: Dysport 300 UNT Injection (Drug)

结局指标

主要结局

PEF (peak expiratory flow)

时间窗: 4-6 weeks

PEF before and 4-6 after BTA injection

FEV1 (forced expiratory volume in one second)

时间窗: 4-6 weeks

FEV1 before and 4-6 after BTA injection

FVC (forced vital capacity)

时间窗: 4-6 weeks

FVC before and 4-6 after BTA injection

次要结局

未报告次要终点

研究者

发起方
Swissmed Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mateusz Zamkowski

Principal Investigator, Director

Swissmed Hospital

研究点 (1)

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