NCT06544200Completed
Intra-operative Air Leak Management After Minimally Invasive Lung Segmental Resection
Intra-operative Air Leak Management After Minimally Invasive Lung Segmental Resection: Randomized Comparison Between Polymeric Hydrogel Matrix and Standard of Care
Source: ClinicalTrials.gov · Last updated 31 Jul 2025
Brief summary (registry, in English)
In patients undergoing minimally invasive thoracoscopic surgery (video-assisted thoracoscopic surgery, or VATS), a still unsolved issue is represented by intraoperative alveolar air leaks (IOAALs), which if prolonged beyond the fifth postoperative day can lead to higher risk of complications and higher medical costs. The polymeric hydrogel matrix (PHM) is a novel tool to manage intraoperative IOAALs. The primary end-point of our study was to verify whether PHM would be able to reduce postoperative air leaks; secondary end-points were the possible reduction of the permanence time of the chest drain (CD) and the hospital length (HL) in the PHM group compared with no treatment.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 104 (actual)
- First submitted
- 30 Jul 2024
- Start date
- 15 Jul 2023
- Primary completion date
- 13 Jul 2024
- Lead sponsor
- University Hospital Padova
- Diseases
- Lung cancer
- NCT number
- NCT06544200
What you commit to
- Study type: Interventional
- Participants enrolled: 104
- From 15 Jul 2023 to the primary completion date, 13 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients undergoing open surgery
- More than one chest tube after lung resection
Other illness
- Chronic Kidney Failure
- Allergies or contraindications to any of the Polymeric Hydrogel Matrix components
Age
- Age \< 18 years
Other
- Refusal or inability to give informed consent to the study protocol
- Pregnancy
- Patients undergoing pulmonary resections different than segmentectomy (wedge, lobectomy, bilobectomy, pneumonectomy)
Who the study is looking for
- patients aged \> 18 years
- undergoing anatomical pulmonary resection (segmentectomy) via VATS or RATS
- benign and/or malignant lung disease
- No known allergy to any of the components of the device
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Thoracic Surgery Unit Coordinator of this site? Confirm its status | Padua | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.