Clinical trial NCT05310539: Early Recovery After "Wedge Resection" Surgery to Remove Lung Mestastasis Secondary to Bone Cancer.
Official title: Rehabilitation Treatment and Early Recovery After "Wedge Resection" for Pulmonary Metastasis Secondary to Bone Cancer: an Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastasis Lung
Bone Neoplasm
Keywords: pulmonary rehabilitation
wedge resection
early recovery
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 75
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients admitted to the ward with a diagnosis of pulmonary metastases from bone cancer will be enrolled consecutively for the study.

Brief summary: After "wedge resection" surgery, the physiotherapy programs proposed in the literature are heterogeneous and there are few data on the outcomes of such treatments in an oncological population for bone cancer.

The aim of the study is to describe the early rehabilitation process after wedge resection surgery secondary to bone tumor pulmonary mestasasis, highlightining the possible functional recovery in the short and medium term after surgery and indentifying the possible prognostic factors.

Detailed description: In Italy, the incidence of primary bone tumors is around 0.8-1 case per 100,000 inhabitants, therefore an estimated 500 new cases of primary malignant bone tumors are estimated each year, affecting more frequently in children and young people. The presence of pulmonary metastasis occurs in 30% of the population with bone cancer and is the most common site of metastasis. Where possible, the elective treatment of lung metastases is ablative surgery and the wedge resection technique is also commonly used in the event of repeated metastasis over time. Pulmonary wedge resection surgery does not follow the anatomical limits of the lung but it is customized according to the metastatic area to be removed, thus differentiating itself from lobectomies and other thoracotomy surgical techniques.

The trend of vital capacity (CV) and forced expiratory volume in 1s (FEV1), after wedge resection surgery, significantly decrease at 3 months compared to the preoperative evaluation, while at 12 months the CV returns to values close to the preoperative ones and FEV1 remains significantly lower. Rehabilitation treatment is part of the multidisciplinary approach for this type of patient in order to prevent post-surgical respiratory complications (PPC) and shoulder girdle dysfunctions, in the treatment of pain and in the recovery of respiratory volumes. Several authors, describing the physiotherapy treatment techniques, include breathing exercises (Active Cycle Breathing Techniques), early mobilization exercises for the lower limbs and the use of volume incentives. The physiotherapy treatment programs proposed in the literature are heterogeneous and there are no data on the feasibility of such treatments in an oncological population for bone cancer.

Patients are enrolled consecutively in a ward of an italian hospital specialized in bone tumor surgery.

Eligibility criteria: Inclusion Criteria:

* over 12 years of age
* ablative thoracic surgery for metastases localized to the lung and / or chest wall for primary bone cancer
* must be able to perform the "one minute sit-to-stand" test in the preoperative physiotherapy evaluation

Exclusion Criteria:

* ablative thoracic surgery for a diagnosis DIFFERENT FROM that of lung metastases

Primary outcomes:
measure: 1 minute sit to stand (Sixth day after surgery)
timeFrame: Sixth day after surgery
Secondary outcomes:
measure: 1 minute sit to stand (daily)
timeFrame: every day after surgery up to 7 day; at 3, 6 and 12 months after surgery.
measure: pain intensity
timeFrame: every day after surgery up to 7 day, twice a day
measure: vital capacity (ml)
timeFrame: every day after surgery up to 7 day, twice a day
measure: heart rate (bpm)
timeFrame: once a day, before and after 1 minute sit to stand test, up to 7 day
measure: peripheral oxygen saturation (SpO2 %)
timeFrame: once a day, before and after 1 minute sit to stand test, up to 7 day
measure: mBorg Score
timeFrame: once a day, before and after 1 minute sit to stand test, up to 7 day
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
state: Emilia Romagna
Study officials:
affiliation: IOR - Istituto Ortopedico Rizzoli
name: marco cotti, pt
role: PRINCIPAL_INVESTIGATOR
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