Clinical trial NCT06732193: Fissios© and Postoperative Complications (FPoC Trial)
Official title: Clinical Trial Comparing a Face-to-face Perioperative Respiratory Physiotherapy Program Versus the Use of Fissios App© as a Complement to a Respiratory Physiotherapy Program in Patients Diagnosed With NSCLC Undergoing Surgery.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgical Procedure, Unspecified
Non Small Cell Lung Cancer
Surgery Scheduled
Thoracic Surgery
Postoperative Complications
Perioperative Care
Keywords: Respiratory physiotherapy
Smartphone App
Post-operative complications
Peri-operative physical training
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
Collaborators: name: Spanish Society of Pneumology and Thoracic Surgery (SEPAR)
name: Asociación Española de Afectados de Cáncer de Pulmón (AEACaP)
name: Medtronic General Research Grant
name: Spanish Society of Thoracic Surgery (SECT)
First posted: 2024-12-13
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Respiratory physiotherapy as part of a pre-operative physical training program may reduce the risk of developing post-operative complications, improving post-operative results and optimizing physical conditions in patients with a diagnosis of non-small cell lung cancer (NSCLC) undergoing lung resection surgery. During the post-operative period, performing physical exercise has also been proved to increase the capacity for exercise, improve health-related quality of life and reduce the feeling of breathlessness. Fissios App is a tool created by thoracic surgeons, physiotherapists and a specialist doctor in physical medicine and rehabilitation, which has been satisfactorily implemented in thoracic surgery patients; this contains a program of standardized respiratory physiotherapy exercises with a defined time and number of repetitions.

The aim is to compare the effectiveness of use of the Fissios App tool as a complement to a peri-operative respiratory physiotherapy program compared to just attendance at a face-to-face peri-operative respiratory physiotherapy program, to reduce the incidence of post-operative complications.

It is expected to include 560 patients in the study. Subsequent to evaluation by the investigator and the acceptance of participant to take part in the study, the performing of peri-operative respiratory physiotherapy is prescribed. The participants will be randomly assigned to a study group that uses the tool as a complement to the respiratory physiotherapy program or a control group that should only attend face-to-face respiratory physiotherapy sessions. All the participants should attend face-to-face respiratory physiotherapy classes taught by physiotherapists at the place and time set out in each centre before and after surgery for at least 45 minutes and at least five sessions. Moreover, study group participants may use the Fissios App tool. Investigators should fill in the pre-operative, surgery and post-operative data for each patient on the Fissios Research platform.

Detailed description: The FPoC Trial is designed as a multicentre, prospective, randomised, prospective, parallel, two-group, controlled, open-label, superiority study of only face-to-face respiratory physiotherapy or the use of Fissios App© as an adjunct to respiratory physiotherapy in patients scheduled for lung resection surgery.

The participants who take part in the study will be randomly assigned to the study or control group before the surgical procedure. All of them will follow an in-person respiratory physiotherapy programme, and the study group will complement this programme with the use of the Fissios App tool.

Perioperative care will be carried out in accordance with national and international guidelines. Postoperative complications will be recorded following the established definitions of the European Society of Thoracic Surgeons (ESTS) database and in the study protocol.

Finally, all the participants will be followed up for 90 days after the date of surgery to finalise the present study. The participants will continue the revisions following the protocols of each centre.

An estimated total of 560 particpants (280 per group) will be recruited for this study.

Eligibility criteria: Inclusion Criteria:

1. Patients over 18 years of age.
2. Indication for lung resection surgery due to diagnostic suspicion or histopathological diagnosis of non-small cell lung carcinoma.
3. Anatomical lung resection surgery: anatomical segmental resection, lobectomies or pneumonectomies, using a conventional or minimally invasive approach (VATS, RATS).
4. The patient has a smart mobile device compatible with the Fissios App©, has the ability or has the support to use it.
5. Willingness and commitment to participate in the study.
6. Ability to complete the informed consent to participate in the study.

Exclusion Criteria:

1. Medical contraindication to perform respiratory physiotherapy exercises.
2. Not possessing a smart mobile device compatible with Fissios App©.
3. Inability of the patient to perform the exercises, either due to a physical or psychological impediment.
4. Inability to complete the informed consent form for participation in the study.
5. Refusal to participate in the study.

Primary outcomes:
measure: Postoperative complications
timeFrame: Through postoperative evolution, an average of 2 weeks.
Secondary outcomes:
measure: Duration of pleural drainage
timeFrame: Through postoperative evolution, an average of 2 weeks.
measure: Mortality
timeFrame: During hospitalization period, an average of 2 weeks.
measure: Hospital readmission
timeFrame: Within 30 days of discharge from hospital
measure: Mortality
timeFrame: During the first 30 days after surgery
measure: Mortality
timeFrame: During the first 90 days after surgery
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
Study officials:
affiliation: Hospital San Carlos, Madrid
name: Carlos A Fraile Olivero, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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