FOREseal生物可吸收加固套管与当前降低恶性肿瘤肺切除术后漏气持续时间的护理标准的医学和经济评估：一项随机试验。

Medical and Economic Evaluation of FOREseal Bioabsorbable Reinforcement Sleeves Compared With Current Standard of Care for Reducing Air Leakage Duration After Lung Resection for Malignancy: A Randomized Trial.

作者信息

Alifano Marco, Jayle Christophe, Bertin François, Magdeleinat Pierre, Castier Yves, Tiffet Olivier, Bernard Alain, Tronc François, Brichon Pierre-Yves, Dumont Pascal, Grosdidier Gilles, Dujon Antoine, Grine Abel, Pereira Helena, Le Jeannic Anais, Vinet Marie Amélie, MaOulida Hassani, Durand-Zaleski Isabelle, Riquet Marc, Chatellier Gilles, Regnard Jean-François

机构信息

*Department of Thoracic Surgery, Paris Center University Hospital, Paris Descartes University, Paris, France †Department of Thoracic Surgery, Poitiers University Hospital, Poitiers, France ‡Department of Thoracic Surgery, Limoges University Hospital, Limoges, France §Department of Thoracic Surgery, Institute Mutualiste Montsouris, Paris, France ||Department of Thoracic Surgery, Bichat University Hospital, Paris Diderot University, Paris, France ¶Department of Thoracic Surgery, St Etienne University Hospital, St Etienne, France #Department of Thoracic Surgery, Dijon University Hospital, Dijon, France **Department of Thoracic Surgery, Lyon University Hospital, Bron, France ††Department of Thoracic Surgery, Grenoble University Hospital, Grenoble, France ‡‡Department of Thoracic Surgery, Tours University Hospital, Tours, France §§Department of Thoracic Surgery, Nancy University Hospital, Nancy, France ||||Department of Thoracic Surgery, Clinique du Cedre, Rouen, France ¶¶Department of Biostatistics, Paris West University Hospital, Paris, France ##Department of Public Health and Medical Economy, Paris Center University Hospital, Paris, France ***Department of Thoracic Surgery, Paris West University Hospitals, AP-HP, Paris Descartes University, Paris, France.

出版信息

Ann Surg. 2017 Jan;265(1):45-53. doi: 10.1097/SLA.0000000000001687.

DOI:10.1097/SLA.0000000000001687

PMID:28009728

Abstract

OBJECTIVE

The objective of this study was to determine the efficacy of alginate staple-line reinforcement of fissure openings as compared with stapling alone, with or without tissue sealant or glue, in reducing the incidence and duration of air leakage after pulmonary lobectomy for malignancy.

SUMMARY BACKGROUND DATA

No randomized trial evaluating alginate staple-line reinforcement has been performed to date.

METHODS

The Staple-line Reinforcement for Prevention of Pulmonary Air Leakage study was a multicenter randomized trial, with blinded evaluation of endpoints. Patients over 18 years of age scheduled for elective open lobectomy or bilobectomy for malignancy were eligible for enrollment. At thoracotomy, patients were deemed ineligible if an unanticipated pneumonectomy was indicated, or if air leakage occurred after the liberation of pleural adhesions. Otherwise, if the fissure was incomplete or the lung had an emphysematous appearance, patients were randomized to either standard management or interventional procedure consisting of fissure opening with linear cutting staplers buttressed with paired alginate sleeves (FOREseal). The number of eligible patients necessary in each randomization arm was estimated to be 190, and an outcomes analysis was performed on an intention-to-treat basis.

RESULTS

Of the 611 patients consented to study enrollment, 380 met the inclusion criteria and were randomized. Based on an intention-to-treat analysis, the primary endpoint of air leak duration was not different between the 2 groups: 1 day (range: 0-2 d) in the FOREseal group and 1 day (range: 0-3 d) in the control group (P = 0.8357). In addition, the 2 groups were similar in terms of the proportion of patients presenting with prolonged air leakage (7.8% in the FOREseal group vs 11.3% in the control group, P = 0.264) and the average duration of chest drainage (P = 0.107). Procedure costs were comparable for both groups.

CONCLUSIONS

FOREseal did not demonstrate a significant advantage over standard treatment alone.

摘要

目的

本研究的目的是确定与单纯吻合器缝合相比，使用藻酸盐缝线加强裂开口（无论是否使用组织密封剂或胶水）在降低恶性肿瘤肺叶切除术后漏气发生率和持续时间方面的疗效。

总结背景数据

迄今为止，尚未进行评估藻酸盐缝线加强的随机试验。

方法

“缝线加强预防肺漏气”研究是一项多中心随机试验，对终点进行盲法评估。计划进行择期开放性肺叶切除术或双叶切除术治疗恶性肿瘤的18岁以上患者符合入组条件。开胸手术时，如果需要进行意外的肺切除术，或者在胸膜粘连松解后出现漏气，则患者被视为不符合条件。否则，如果裂不完整或肺呈气肿外观，患者被随机分为标准治疗组或干预组，干预组采用带配对藻酸盐套管（FOREseal）的线性切割吻合器打开裂。每个随机分组的合格患者数量估计为190例，并基于意向性分析进行结果分析。

结果

在611名同意参加研究的患者中，380名符合纳入标准并被随机分组。基于意向性分析，两组的主要终点漏气持续时间没有差异：FOREseal组为1天（范围：0 - 2天），对照组为1天（范围：0 - 3天）（P = 0.8357）。此外，两组在出现长时间漏气的患者比例（FOREseal组为7.8%，对照组为11.3%，P = 0.264）和胸腔引流平均持续时间方面相似（P = 0.107）。两组的手术成本相当。