Complete resection in lung cancer surgery: proposed definition.
Ramón Rami-Porta, Christian Wittekind, Peter Goldstraw...
https://pubmed.ncbi.nlm.nih.gov/15949587/Actively Recruiting
Led by Carlos Alfredo Fraile Olivero, MD, PhD. · Updated on 2025-09-11
560
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are studying respiratory physiotherapy as part of a physical training program before and after lung resection surgery in patients with non-small cell lung cancer NSCLC. The goal is to see if using the Fissios App alongside face-to-face respiratory physiotherapy reduces post-operative complications compared to face-to-face physiotherapy alone. This study is a multicenter, randomized, open-label trial with two groups, aiming to improve post-operative outcomes and physical condition. Participants will be randomly assigned to either receive only face-to-face respiratory physiotherapy sessions or to receive these sessions plus use the Fissios App, which provides guided respiratory exercises. All participants must attend at least five in-person physiotherapy sessions before and after surgery, each lasting at least 45 minutes. The study group will be encouraged to use the Fissios App freely at any time and place. Lung surgeries include segmental resection, lobectomy, or pneumonectomy, performed either conventionally or minimally invasively. During the study, researchers will collect pre-operative, surgical, and post-operative data on the Fissios Research platform. Patients will be followed for 90 days after surgery to monitor complications, length of drainage, mortality, and hospital readmissions. The trial includes detailed recording of post-operative outcomes using standardized definitions and aims to recruit around 560 participants in total.
CONDITIONS
Fissios© and Postoperative Complications (FPoC Trial)
C
Carlos A Fraile Olivero, MD, PhD
L
Lidia Sotillo, MD
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Carlos Alfredo Fraile Olivero, MD, PhD.
Lead Sponsor
Spanish Society of Pneumology and Thoracic Surgery (SEPAR)
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Pre-surgery period as per centre protocol
Participants are randomly assigned to either face-to-face respiratory physiotherapy alone or face-to-face respiratory physiotherapy plus the use of the Fissios App before surgery.
Multiple visits depending on centre schedule
Duration - Hospitalization period (approximately 2 weeks)
Participants undergo lung resection surgery and receive perioperative care according to national and international guidelines.
Hospital visits during hospitalization
Duration - Up to 90 days after surgery
Participants continue respiratory physiotherapy sessions and, if assigned, use the Fissios App. Postoperative complications are monitored and recorded following established definitions.
Follow-up visits according to centre protocols
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor
Spanish Society of Pneumology and Thoracic Surgery (SEPAR)
Collaborating Sponsor