Compliance-guided Closure Strategy for Large Ventral Hernia Repair

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial is a prospective, single-arm interventional study in adults undergoing elective repair of large ventral hernias after botulinum toxin A prehabilitation. Intraoperative decisions about abdominal wall closure are guided by static respiratory system compliance measured at three timepoints, with a rule that closure should be considered tolerable if compliance remains at least 70% of baseline. If compliance drops, the team may choose an alternative closure approach to reduce risk of respiratory complications. Primary outcome is the rate of early postoperative respiratory failure within 72 hours. Data are collected via a dedicated case report form, with standardized volume-controlled ventilation and neuromuscular blockade during measurements.

Why it matters

Who can join: the full rules

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)

Where it's running

• LUX MED Hospital, Gdańsk
  Gdansk, Poland Recruiting

Study contacts

• Principal investigator: Irmina Anna Śmietański, MD, PhD — Śmietański Hernia Center, LUX MED Hospital in Gdańsk
• Study coordinator: Magdalena Halska
• Email: worldofsurge@gmail.com
• Phone: 607870690

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.