Evaluating air leakage from staple line reinforcements in anatomical pulmonary resection (AIRSTOP): a prospective randomized controlled trial protocol
Abstract
Air leakage during pulmonary resection is a major complication in thoracic surgery. It frequently occurs at sites of adhesion dissection, due to lung manipulation, and along the staple lines of automatic suturing devices, particularly in cases of pulmonary fragility such as those of emphysema and interstitial pneumonia. Persistent postoperative air leakage prolongs chest tube indwelling and extends hospitalization time. Staplers with absorbable tissue reinforcements have been introduced for pulmonary resection to prevent intraoperative stapler-related air leakage. This phase II prospective, open-label, randomized, parallel-group trial aims to validate the efficacy of staplers with or without absorbable tissue reinforcements in controlling stapler-related air leakage during anatomical pulmonary resections. Overall, 120 patients will be randomized into two groups: one that will undergo conventional anatomical pulmonary resection and the other in which staplers with absorbable tissue reinforcements will be used. The primary endpoint will be intraoperative stapler-related air leakage. Data will be analyzed between 2024 and 2025. This trial will validate the effectiveness and safety of staple line reinforcements in controlling intraoperative air leakage during anatomical pulmonary resections, potentially leading to optimized strategies for patients with conditions such as emphysema and interstitial pneumonia. This trial has been registered with the Japan Registry of Clinical…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 120 participants or records.
Read the paper
Related studies
- Penicillins for Treatment of Pneumococcal Pneumonia: Does In Vitro Resistance Really Matter?
- Thiophenes—Naturally Occurring Plant Metabolites: Biological Activities and In Silico Evaluation of Their Potential as Cathepsin D Inhibitors
- Inhalable Mannosylated Rifampicin–Curcumin Co-Loaded Nanomicelles with Enhanced In Vitro Antimicrobial Efficacy for an Optimized Pulmonary Tuberculosis Therapy
- Development and validation of microbial bioassay for quantification of Levofloxacin in pharmaceutical preparations
- GC-MS Analysis and Biomedical Therapy of Oil from n-Hexane Fraction of Scutellaria edelbergii Rech. f.: In Vitro, In Vivo, and In Silico Approach
- Propranolol, chlorpromazine and diclofenac restore susceptibility of extensively drug-resistant (XDR)-Acinetobacter baumannii to fluoroquinolones
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.