Impact of a Compliance-Guided Intraoperative Abdominal Wall Closure Decision Strategy on Early Postoperative Respiratory Failure After Large Ventral Hernia Repair Following Preoperative Botulinum Toxin A
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Incidence of postoperative respiratory failure within 72 hours
研究概览
简要总结
People undergoing repair of large ventral hernias can develop breathing problems after surgery, especially around the time when the abdominal wall is closed. During closure, pressure inside the abdomen may increase and lung mechanics can worsen. This study will evaluate a structured intraoperative decision approach that uses standard anesthesia measurements of static respiratory system compliance at predefined timepoints to support the choice of abdominal wall closure technique. The main goal is to assess the rate of early postoperative respiratory failure within 72 hours after surgery.
详细描述
This is a prospective, single-arm, decision-guided interventional study in adults undergoing elective repair of large ventral hernias after preoperative botulinum toxin A preparation as part of the local prehabilitation pathway. The study focuses on the intraoperative abdominal wall closure phase, when physiological changes may increase the risk of early postoperative respiratory complications.
Mechanical ventilation is standardized during measurement timepoints using volume-controlled ventilation with tidal volume set to 6 mL per kg of ideal body weight and a positive end-expiratory pressure of 10 cmH2O. Full neuromuscular blockade is ensured to minimize measurement variability. Static respiratory system compliance is recorded at three predefined timepoints: after endotracheal intubation before skin incision (baseline), during abdominal wall closure (decision timepoint), and before extubation. The intraoperative decision strategy considers a closure physiologically tolerable when static compliance remains at least 70 percent of the baseline value. If compliance falls below this threshold at the closure decision timepoint, the surgical team considers avoiding tension closure and may use a bridging or alternative closure approach according to clinical judgment. When intra-abdominal pressure is measured as part of routine care, these values are recorded as an additional physiological parameter.
Perioperative data are captured in a dedicated case report form, and patients are observed for early respiratory outcomes during the first 72 hours after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 否
入选标准
- •Age 18 years or older
- •Elective repair of a large ventral abdominal wall hernia (including incisional hernia)
- •Preoperative botulinum toxin A preparation performed as part of the local prehabilitation pathway
- •Preoperative abdominal CT available
- •General anesthesia with mechanical ventilation and feasibility of standardized intraoperative respiratory mechanics measurements
排除标准
- •Severe preoperative respiratory failure judged to preclude standardized intraoperative respiratory mechanics assessment
- •Inability to obtain reliable static respiratory system compliance measurements at predefined timepoints
- •Hemodynamic instability preventing protocolized measurements (as judged by the anesthesiologist)
研究组 & 干预措施
Compliance-Guided Closure Strategy
Participants undergo elective large ventral hernia repair after preoperative botulinum toxin A preparation. During surgery, a predefined intraoperative decision strategy is applied during abdominal wall closure using standardized measurements of static respiratory system compliance (Cstat) at predefined timepoints (baseline after intubation before incision, during closure as the decision point, and before extubation). Standardized ventilation settings are used during measurements (volume-controlled ventilation, tidal volume 6 mL/kg ideal body weight, PEEP 10 cmH2O) with full neuromuscular blockade. A closure is considered physiologically tolerable when Cstat remains at least 70 percent of baseline; if Cstat decreases below this threshold during closure, the surgical team considers avoiding tension closure and may use a bridging or alternative closure approach according to clinical judgment. When intra-abdominal pressure is measured as part of routine care, values are recorded.
干预措施: Compliance-Guided Abdominal Wall Closure Decision Strategy (Other)
结局指标
主要结局
Incidence of postoperative respiratory failure within 72 hours
时间窗: Within 72 hours after surgery
Percentage of participants who develop postoperative respiratory failure within 72 hours after surgery, defined as meeting ≥1 of the following criteria: * Reintubation for respiratory reasons; OR * Non-invasive ventilation (NIV) or high-flow nasal oxygen (HFNO) delivered for \>6 consecutive hours for respiratory reasons; OR * Escalation of respiratory support for respiratory reasons (e.g., increase in oxygen delivery device/flow/FiO₂ or ventilatory support level). Unit of measure / tool: % of participants (derived from routine clinical documentation: anesthesia record, PACU/ICU charts, respiratory therapy notes).
次要结局
- Change in static respiratory system compliance from baseline to closure decision(Intraoperative (baseline to closure decision timepoint))
- Proportion of cases requiring change in abdominal wall closure strategy(Intraoperative (during abdominal wall closure))
- Intra-abdominal pressure during abdominal wall closure(Intraoperative (at time of measurement))