Compliance-Guided Abdominal Wall Closure Strategy in Large Ventral Hernia Repair
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSwissmed Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Compliance-Guided Abdominal Wall Closure Decision Strategy
Other interventionA 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Compliance-Guided Closure StrategyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 surgerySecondary outcomes
1
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)2
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)3
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Swissmed Hospital
Lead sponsor
Medical University of Gdansk
Collaborator
Source ClinicalTrials.gov