Fissios and postoperative complications (FPoC trial): a multicentre, randomised, controlled clinical trial.

IF 4 3区医学 Q1 RESPIRATORY SYSTEM

BMJ Open Respiratory Research Pub Date : 2026-06-15 DOI:10.1136/bmjresp-2025-003269

Carlos Alfredo Fraile Olivero, Lidia Sotillo Valenzuela, Verónica Albarrán Vidal, José Gabriel Barceló Cal, Verónica Alen Villamayor, Florentino Hernando Trancho, Elena Fernández Martín, Joaquín Calatayud Gastardi, Ana María Gómez Martínez, Pedro Daniel Arribas Manzanal, Passio Santos, Raquel Fernández Blanco, María Isabel Cal Vázquez, Lucia Milla Collado, María Rodríguez, Valerio Perna, Alejandra Romero Roman, Carlos Andrés Ordonez, José Ramón Jarabo Sarceda

{"title":"Fissios and postoperative complications (FPoC trial): a multicentre, randomised, controlled clinical trial.","authors":"Carlos Alfredo Fraile Olivero, Lidia Sotillo Valenzuela, Verónica Albarrán Vidal, José Gabriel Barceló Cal, Verónica Alen Villamayor, Florentino Hernando Trancho, Elena Fernández Martín, Joaquín Calatayud Gastardi, Ana María Gómez Martínez, Pedro Daniel Arribas Manzanal, Passio Santos, Raquel Fernández Blanco, María Isabel Cal Vázquez, Lucia Milla Collado, María Rodríguez, Valerio Perna, Alejandra Romero Roman, Carlos Andrés Ordonez, José Ramón Jarabo Sarceda","doi":"10.1136/bmjresp-2025-003269","DOIUrl":null,"url":null,"abstract":"Introduction: Respiratory physiotherapy as a part of a perioperative physical training programme may reduce the risk of developing postoperative complications in patients diagnosed with non-small cell lung carcinoma (NSCLC) scheduled for surgery. However, there is heterogeneity in the design, implementation and evaluation of respiratory physiotherapy programmes.Fissios App contains a standardised respiratory physiotherapy programme. Analysing the usage data, the patient's personal history, the surgical procedure and the postoperative course, we will establish the relationship between compliance with a standardised respiratory physiotherapy programme and the development of postoperative complications in a group of patients diagnosed with NSCLC who underwent lung resection surgery.Methods and analysis: The Fissios and postoperative complications trial is a multicentre, prospective, randomised, parallel two-group, controlled, open-label, superiority study of the use of only face-to-face respiratory physiotherapy or the use of Fissios App as a complement to respiratory physiotherapy. Based on the percentage of postoperative respiratory complications and the anticipated reduction, a total of 560 patients will be required. Patients will be electronically randomised to the intervention or control group before the surgery with a proportion of 1:1 in blocks of six for each centre.All patients will attend face-to-face respiratory physiotherapy sessions at the place and times established in each centre. In addition, patients in the intervention group will use the Fissios App freely and without restrictions in terms of hour of the day, usage time or location. The primary clinical endpoint is postoperative complications during hospital admission and the estimated duration of the study is 12 months.Ethics and dissemination: This protocol was reviewed and approved by the Clinical Research and Clinical Trials Unit of Hospital Clínico San Carlos (Madrid, Spain) and complies with the ethics principles for medical research on humans stipulated in the Declaration of Helsinki of the World Medical Association.Trial registration number: NCT06732193.","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"13 1","pages":""},"PeriodicalIF":4.0000,"publicationDate":"2026-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13289354/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMJ Open Respiratory Research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1136/bmjresp-2025-003269","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"RESPIRATORY SYSTEM","Score":null,"Total":0}

引用次数: 0

Abstract

Introduction: Respiratory physiotherapy as a part of a perioperative physical training programme may reduce the risk of developing postoperative complications in patients diagnosed with non-small cell lung carcinoma (NSCLC) scheduled for surgery. However, there is heterogeneity in the design, implementation and evaluation of respiratory physiotherapy programmes.Fissios App contains a standardised respiratory physiotherapy programme. Analysing the usage data, the patient's personal history, the surgical procedure and the postoperative course, we will establish the relationship between compliance with a standardised respiratory physiotherapy programme and the development of postoperative complications in a group of patients diagnosed with NSCLC who underwent lung resection surgery.

Methods and analysis: The Fissios and postoperative complications trial is a multicentre, prospective, randomised, parallel two-group, controlled, open-label, superiority study of the use of only face-to-face respiratory physiotherapy or the use of Fissios App as a complement to respiratory physiotherapy. Based on the percentage of postoperative respiratory complications and the anticipated reduction, a total of 560 patients will be required. Patients will be electronically randomised to the intervention or control group before the surgery with a proportion of 1:1 in blocks of six for each centre.All patients will attend face-to-face respiratory physiotherapy sessions at the place and times established in each centre. In addition, patients in the intervention group will use the Fissios App freely and without restrictions in terms of hour of the day, usage time or location. The primary clinical endpoint is postoperative complications during hospital admission and the estimated duration of the study is 12 months.

Ethics and dissemination: This protocol was reviewed and approved by the Clinical Research and Clinical Trials Unit of Hospital Clínico San Carlos (Madrid, Spain) and complies with the ethics principles for medical research on humans stipulated in the Declaration of Helsinki of the World Medical Association.

Trial registration number: NCT06732193.

查看原文本刊更多论文

裂口和术后并发症（FPoC试验）：一项多中心、随机、对照临床试验。

摘要：呼吸物理治疗作为围手术期体能训练计划的一部分，可以降低诊断为非小细胞肺癌（NSCLC）的患者手术后并发症的发生风险。然而，呼吸物理治疗方案的设计、实施和评估存在异质性。Fissios App包含一个标准化的呼吸物理治疗程序。通过分析使用数据、患者的个人病史、手术过程和术后过程，我们将在一组诊断为NSCLC并接受肺切除术的患者中建立标准化呼吸物理治疗方案的依从性与术后并发症发生之间的关系。方法和分析：Fissios和术后并发症试验是一项多中心、前瞻性、随机、平行、双组、对照、开放标签、优势研究，仅使用面对面呼吸物理治疗或使用Fissios App作为呼吸物理治疗的补充。根据术后呼吸系统并发症的百分比和预期的减少，总共需要560名患者。手术前，患者将以电子方式随机分配到干预组或对照组，每个中心按1:1的比例分为六个组。所有患者将在每个中心指定的地点和时间参加面对面的呼吸物理治疗课程。此外，干预组患者可以自由使用Fissios App，不受时间、使用时间和地点的限制。主要临床终点是住院期间的术后并发症，估计研究持续时间为12个月。伦理和传播：本议定书经Clínico圣卡洛斯医院临床研究和临床试验部门（西班牙马德里）审查和批准，符合《世界医学协会赫尔辛基宣言》规定的人体医学研究伦理原则。试验注册号：NCT06732193。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

BMJ Open Respiratory Research RESPIRATORY SYSTEM-

CiteScore

6.60

自引率

2.40%

发文量

审稿时长

12 weeks

期刊介绍： BMJ Open Respiratory Research is a peer-reviewed, open access journal publishing respiratory and critical care medicine. It is the sister journal to Thorax and co-owned by the British Thoracic Society and BMJ. The journal focuses on robustness of methodology and scientific rigour with less emphasis on novelty or perceived impact. BMJ Open Respiratory Research operates a rapid review process, with continuous publication online, ensuring timely, up-to-date research is available worldwide. The journal publishes review articles and all research study types: Basic science including laboratory based experiments and animal models, Pilot studies or proof of concept, Observational studies, Study protocols, Registries, Clinical trials from phase I to multicentre randomised clinical trials, Systematic reviews and meta-analyses.