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

NCT07422441 | Not Yet Recruiting

• 1 other identifier: CLOSE
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

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

Outcome Measures

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).

  Within 72 hours after surgery

Secondary Outcomes (3)

• Change in static respiratory system compliance from baseline to closure decision

  Intraoperative (baseline to closure decision timepoint)

• Proportion of cases requiring change in abdominal wall closure strategy

  Intraoperative (during abdominal wall closure)

• Intra-abdominal pressure during abdominal wall closure

  Intraoperative (at time of measurement)

Study Arms (1)

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.

Other: Compliance-Guided Abdominal Wall Closure Decision Strategy

Interventions

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.

Also known as: Static Compliance-Guided Closure Algorithm, Cstat-Guided Closure Strategy, Physiology-Guided Abdominal Wall Closure

Compliance-Guided Closure Strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Swissmed Hospital: lead
• Medical University of Gdansk: collaborator

MeSH Terms

Conditions

Hernia, Ventral; Incisional Hernia; Postoperative Complications; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• 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

• Mateusz Zamkowski, MD, PhD

  Śmietański Hernia Center, LUX MED Hospital in Gdańsk

  STUDY DIRECTOR

Central Study Contacts

Magdalena Halska

CONTACT

607870690; worldofsurge@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm, decision-guided intraoperative closure strategy based on predefined static compliance measurements at three timepoints.

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 20, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share