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Completed

NCT Number: NCT05310539

Early Recovery After "Wedge Resection" Surgery to Remove Lung Mestastasis Secondary to Bone Cancer.

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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Ortopedico Rizzoli

Bologna, Emilia-Romagna, 40136, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

assessment of the early recovery after wedge resection surgery

Other

To assess the early recovery will be used 1 minute sit to stand, Numeric Rating scale to assess pain, incentive spirometer to assess vital capacity, Borg modified scale to assess dyspnea.

Primary outcomes

  1. 1 minute sit to stand (Sixth day after surgery)

    Time frame: Sixth day after surgery

    The test requires the person to stand up from a chair, without the help of the arms, fully extending their knees, and sit down the greatest number of times in the time of one minute.

Secondary outcomes

  1. 1 minute sit to stand (daily)

    Time frame: every day after surgery up to 7 day; at 3, 6 and 12 months after surgery.

    The test requires the person to stand up from a chair, without the help of the arms, fully extending their knees, and sit down the greatest number of times in the time of one minute.

  2. pain intensity

    Time frame: every day after surgery up to 7 day, twice a day

    numeric rating scale (from 0 (no pain) to 10 (worst possible pain))

  3. vital capacity (ml)

    Time frame: every day after surgery up to 7 day, twice a day

    the vital capacity will be assess with incentive spirometer named "respirex"

  4. heart rate (bpm)

    Time frame: once a day, before and after 1 minute sit to stand test, up to 7 day

    beats per minute; it will be assess with pulse oximeter

  5. peripheral oxygen saturation (SpO2 %)

    Time frame: once a day, before and after 1 minute sit to stand test, up to 7 day

    it will be assess with pulse oximeter

  6. mBorg Score

    Time frame: once a day, before and after 1 minute sit to stand test, up to 7 day

    dyspnea (shortness of breath, sometimes described as "air hunger") it will be assess using Borg Modified Scale, from 0 to 10, when 0 means "none" (better outcome) and 10 means "maximum" (worse outcome).

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

Rehabilitation Treatment and Early Recovery After "Wedge Resection" for Pulmonary Metastasis Secondary to Bone Cancer: an Observational Study.

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 5, 2022
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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