Intra-operative Air Leak Management After Minimally Invasive Lung Segmental Resection (NCT06544200) | Clinical Trial Compass
CompletedNot Applicable
Intra-operative Air Leak Management After Minimally Invasive Lung Segmental Resection
Italy104 participantsStarted 2023-07-15
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Refusal or inability to give informed consent to the study protocol
* Age \< 18 years
* Pregnancy
* Chronic Kidney Failure
* Allergies or contraindications to any of the Polymeric Hydrogel Matrix components
* Patients undergoing pulmonary resections different than segmentectomy (wedge, lobectomy, bilobectomy, pneumonectomy)
* Patients undergoing open surgery
* More than one chest tube after lung resection
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
presence of postoperative air leaks
Timeframe: days from end of surgery up to 40 days of postoperative follow-up