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

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.

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.

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.

NCT06732193.