NCT06732193 Fissios© and Postoperative Complications (FPoC Trial)
| NCT ID | NCT06732193 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Carlos Alfredo Fraile Olivero, MD, PhD. |
| Condition | Surgical Procedure, Unspecified |
| Study Type | INTERVENTIONAL |
| Enrollment | 560 participants |
| Start Date | 2025-03-20 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 560 participants in total. It began in 2025-03-20 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Carlos A Fraile Olivero, MD, PhD
PRINCIPAL INVESTIGATOR
Hospital San Carlos, Madrid
Frequently Asked Questions
Who can join the NCT06732193 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Surgical Procedure, Unspecified. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06732193 currently recruiting?
Yes, NCT06732193 is actively recruiting participants. Contact the research team at carlosalfredo.fraile@salud.madrid.org for enrollment information.
Where is the NCT06732193 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT06732193 clinical trial?
NCT06732193 is sponsored by Carlos Alfredo Fraile Olivero, MD, PhD.. The principal investigator is Carlos A Fraile Olivero, MD, PhD at Hospital San Carlos, Madrid. The trial plans to enroll 560 participants.