An interventional study of Compliance-Guided Abdominal Wall Closure Decision Strategy in Hernia, Ventral, Hernia Incisional and Postoperative Complications, sponsored by Swissmed Hospital. Recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Swissmed Hospital · Not applicable, Interventional, and Prevention
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.
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.
230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.
This study's planned enrollment of 50 is below the median of 90 across 153 interventional studies indexed under Hernia, Ventral.
Browse Hernia, Ventral studies →Swissmed Hospital is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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.
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.
Also known as: Static Compliance-Guided Closure Algorithm, Cstat-Guided Closure Strategy, Physiology-Guided Abdominal Wall Closure
Incidence of postoperative respiratory failure within 72 hours
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).
Time frame: Within 72 hours after surgery
Change in static respiratory system compliance from baseline to closure decision
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)
Time frame: Intraoperative (baseline to closure decision timepoint)
Proportion of cases requiring change in abdominal wall closure strategy
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).
Time frame: Intraoperative (during abdominal wall closure)
Intra-abdominal pressure during abdominal wall closure
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.
Time frame: Intraoperative (at time of measurement)
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Nov 2026, 8 months after the start.
Of 75 non-industry interventional studies with no phase under Hernia, Ventral, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 48. This study's planned 8 months is below that.
Counting every sponsor, half of 88 studies reached it within 37 months; a quarter within 19 and three quarters within 56.
Primary completion moved once since we started tracking on Sep 25, 2026: Aug 2026 → Nov 2026, on Oct 7, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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