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NCT Number: NCT07422441

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

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.

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Key information

Conditions

HERNIA, VENTRAL Hernia Hernia Incisional Hernia, Abdominal Incisional Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Compliance-Guided Abdominal Wall Closure Decision Strategy

Other

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.

Other names: Static Compliance-Guided Closure Algorithm, Cstat-Guided Closure Strategy, Physiology-Guided Abdominal Wall Closure

Primary outcomes

  1. Incidence of postoperative respiratory failure within 72 hours

    Time frame: 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).

Secondary outcomes

  1. Change in static respiratory system compliance from baseline to closure decision

    Time frame: Intraoperative (baseline to closure decision timepoint)

    Change in static respiratory system compliance (Cstat) from:

    • Baseline: after intubation, before incision to
    • Closure decision timepoint: immediately prior to the final abdominal wall closure strategy decision

    under standardized ventilation conditions.

    Unit of measure / tool: ΔCstat (mL/cmH₂O) measured/calculated from the mechanical ventilator using:

    • Cstat = VT / (Pplat - PEEP) (if you intend this exact formula, include it)
    • VT, Pplat, PEEP obtained from ventilator readings (anesthesia machine record)

  2. Proportion of cases requiring change in abdominal wall closure strategy

    Time frame: Intraoperative (during abdominal wall closure)

    Percentage of participants in whom the preoperatively planned tension closure is changed at the closure decision timepoint to:

    • bridging, or
    • another predefined alternative closure approach

    based on intraoperative physiological assessment per protocol. Unit of measure / tool: % of participants (surgeon operative report + intraoperative record; categorized closure strategy).

  3. Intra-abdominal pressure during abdominal wall closure

    Time frame: Intraoperative (at time of measurement)

    Intra-abdominal pressure (IAP) values recorded per routine care at prespecified intraoperative timepoints (as applicable in your workflow). If you want one summary statistic, specify it (recommended), e.g.:

    • Peak intraoperative IAP during closure, or
    • IAP at closure decision timepoint Unit of measure / tool: mmHg, measured using the site's routine IAP technique (e.g., bladder pressure via urinary catheter system) as documented in the anesthesia/ICU record.

Study contacts

Contact information is provided by the study sponsor or research team.

Magdalena Halska

CONTACT

[email protected]

607870690

Sponsors and collaborators

Lead sponsor

Swissmed Hospital

Other

Collaborators

  • Medical University of Gdansk

Registry information

Official study 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

Acronym: CLOSE-STAT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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