Compliance-Guided Abdominal Wall Closure Strategy in Large Ventral Hernia Repair (CLOSE-STAT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Complications; Respiratory Insufficiency; Hernia, Ventral; Hernia Incisional
• Intervention / Treatment: Other: Compliance-Guided Abdominal Wall Closure Decision Strategy

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Magdalena Halska; Phone Number: 607870690; Email: worldofsurge@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Compliance-Guided Closure Strategy; 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.; Other Names: Static Compliance-Guided Closure Algorithm; Cstat-Guided Closure Strategy; Physiology-Guided Abdominal Wall Closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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).	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.	Intraoperative (at time of measurement)

Collaborators and Investigators

• Sponsor: Swissmed Hospital
• Collaborators: Medical University of Gdansk
• Investigators: Principal Investigator: Irmina Anna Śmietański, MD, PhD, Śmietański Hernia Center, LUX MED Hospital in Gdańsk; Study Chair: Maciej Śmietański, Prof., Śmietański Hernia Center, LUX MED Hospital in Gdańsk; Study Director: Mateusz Zamkowski, MD, PhD, Śmietański Hernia Center, LUX MED Hospital in Gdańsk

Study record dates

Study Major Dates

• Study Start (Estimated): February 20, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: intra-abdominal pressure; intraoperative monitoring; botulinum toxin a; adbominal wall closure; static compliance; respiratory system compliance; complex hernia repair
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Anatomical; Respiratory Tract Diseases; Respiration Disorders; Hernia; Hernia, Abdominal; Pathological Conditions, Signs and Symptoms; Incisional Hernia; Respiratory Insufficiency; Postoperative Complications; Hernia, Ventral
• Other Study ID Numbers: CLOSE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No