Hernia, VentralCLOSE-STATNCT07422441
Compliance-Guided Abdominal Wall Closure Strategy in Large Ventral Hernia Repair
A study testing Compliance-Guided Abdominal Wall Closure Decision Strategy in people with Hernia, Ventral and Hernia Incisional, run by Swissmed Hospital at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Ventral, Hernia Incisional, Postoperative Complications
- What is being tested?
- Compliance-Guided Abdominal Wall Closure Decision Strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 20 Feb 2026to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
LUX MED Hospital, Gdańsk
Gdansk, 80-215
Magdalena Halska, +48607870690, worldofsurge@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Hernia, Ventral, Hernia Incisional, Postoperative Complications, Respiratory Insufficiency
- Being tested
- Compliance-Guided Abdominal Wall Closure Decision Strategy
- Keywords
- adbominal wall closure, static compliance, respiratory system compliance, intraoperative monitoring, intra-abdominal pressure, complex hernia repair, botulinum toxin a
- Medical subject headings
- Hernia, Ventral, Incisional Hernia, Postoperative Complications, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compliance-Guided Abdominal Wall Closure Decision StrategyOther
Also called Static Compliance-Guided Closure Algorithm, Cstat-Guided Closure Strategy, Physiology-Guided Abdominal Wall Closure
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Compliance-Guided Abdominal Wall Closure Decision Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 72 hours after surgery
Secondary outcomes (3)
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)
Measured: 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).
Measured: 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.
Measured: Intraoperative (at time of measurement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start20 Feb 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, VentralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, decision-guided intraoperative closure strategy based on predefined static compliance measurements at three timepoints.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swissmed Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Gdansk
- Responsible party
- Sponsor
- Investigators
- Irmina Anna Śmietański, MD, PhD, Principal investigator, Śmietański Hernia Center, LUX MED Hospital in GdańskMaciej Śmietański, Prof., Study chair, Śmietański Hernia Center, LUX MED Hospital in GdańskMateusz Zamkowski, MD, PhD, Study director, Śmietański Hernia Center, LUX MED Hospital in Gdańsk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422441
- Sponsor's protocol ID
- CLOSE
- Acronym
- CLOSE-STAT
- Status last verified
- Oct 2026
- First submitted
- 5 Feb 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07422441
- Acronym / sponsor ID
- CLOSE-STAT / CLOSE
- Conditions
- Hernia, Ventral, Hernia Incisional, Postoperative Complications, Respiratory Insufficiency
- Keywords
- adbominal wall closure, static compliance, respiratory system compliance, intraoperative monitoring, intra-abdominal pressure, complex hernia repair, botulinum toxin a
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Swissmed HospitalUniversity, hospital or other
- Collaborators
- Medical University of Gdansk
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, decision-guided intraoperative closure strategy based on predefined static compliance measurements at three timepoints.
| Arm | Type | Receives |
|---|---|---|
| Compliance-Guided Closure Strategy | Experimental | Other: Compliance-Guided Abdominal Wall Closure Decision StrategyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compliance-Guided Abdominal Wall Closure Decision StrategyAlso: Static Compliance-Guided Closure Algorithm, Cstat-Guided Closure Strategy, Physiology-Guided Abdominal Wall ClosureA 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 | Compliance-Guided Closure Strategy |
Primary outcome
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).
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Irmina Anna Śmietański, MD, PhD principal investigator
Śmietański Hernia Center, LUX MED Hospital in Gdańsk
Maciej Śmietański, Prof. study chair
Śmietański Hernia Center, LUX MED Hospital in Gdańsk
Mateusz Zamkowski, MD, PhD study director
Śmietański Hernia Center, LUX MED Hospital in Gdańsk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compliance-Guided Abdominal Wall Closure Decision Strategy in people with Hernia, Ventral and Hernia Incisional, run by Swissmed Hospital at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magdalena Halska (607870690, worldofsurge@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative respiratory failure within 72 hours (time frame: Within 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.