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Not yet recruiting NCT07422441

Compliance-Guided Abdominal Wall Closure Strategy in Large Ventral Hernia Repair

No phase Interventional Hernia, Ventral Hernia Incisional Postoperative Complications Respiratory Insufficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Compliance-Guided Abdominal Wall Closure Decision Strategy.
Who it may be relevant to
Registry conditions: Hernia, Ventral, Hernia Incisional, Postoperative Complications, Respiratory Insufficiency. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other Compliance-Guided Abdominal Wall Closure Decision Strategy
    A predefined intraoperative decision strategy that uses standardized measurements of static respiratory system compliance (Cstat) during abdominal wall closure to support selection of closure technique, with a predefined physiological tolerance threshold based on the baseline measurement.

Primary outcome measures

  • Incidence of postoperative respiratory failure within 72 hours [Time frame: Within 72 hours after surgery]
Secondary outcome measures (3)
  • Change in static respiratory system compliance from baseline to closure decision [Time frame: Intraoperative (baseline to closure decision timepoint)]
  • Proportion of cases requiring change in abdominal wall closure strategy [Time frame: Intraoperative (during abdominal wall closure)]
  • Intra-abdominal pressure during abdominal wall closure [Time frame: Intraoperative (at time of measurement)]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07422441 · CLOSE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗