Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medical University of Gdansk | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compliance-Guided Closure Strategy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
Unit of measure / tool: % of participants (derived from routine clinical documentation: anesthesia record, PACU/ICU charts, respiratory therapy notes). | Within 72 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in static respiratory system compliance from baseline to closure decision | Change in static respiratory system compliance (Cstat) from:
under standardized ventilation conditions. Unit of measure / tool: ΔCstat (mL/cmH₂O) measured/calculated from the mechanical ventilator using:
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Magdalena Halska | Contact | 607870690 | worldofsurge@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Irmina Anna Śmietański, MD, PhD | Śmietański Hernia Center, LUX MED Hospital in Gdańsk | Principal Investigator |
| Maciej Śmietański, Prof. | Śmietański Hernia Center, LUX MED Hospital in Gdańsk | Study Chair |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| D000069290 | Incisional Hernia |
| D011183 | Postoperative Complications |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Single-arm, decision-guided intraoperative closure strategy based on predefined static compliance measurements at three timepoints.
Not provided
Not provided
Not provided
Not provided
|
|
| 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:
based on intraoperative physiological assessment per protocol. Unit of measure / tool: % of participants (surgeon operative report + intraoperative record; categorized closure strategy). | 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.:
| Intraoperative (at time of measurement) |
| Mateusz Zamkowski, MD, PhD | Śmietański Hernia Center, LUX MED Hospital in Gdańsk | Study Director |
| D010335 | Pathologic Processes |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |