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

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

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.

Study Overview

• Status: Completed
• Conditions: Metastasis Lung; Bone Neoplasm
• Intervention / Treatment: Other: assessment of the early recovery after wedge resection surgery

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.

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• Italy
  • Emilia Romagna
    • Bologna, Emilia Romagna, Italy, 40136
      • Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1 minute sit to stand (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.	Sixth day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1 minute sit to stand (daily)	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.	every day after surgery up to 7 day; at 3, 6 and 12 months after surgery.
pain intensity	numeric rating scale (from 0 (no pain) to 10 (worst possible pain))	every day after surgery up to 7 day, twice a day
vital capacity (ml)	the vital capacity will be assess with incentive spirometer named "respirex"	every day after surgery up to 7 day, twice a day
heart rate (bpm)	beats per minute; it will be assess with pulse oximeter	once a day, before and after 1 minute sit to stand test, up to 7 day
peripheral oxygen saturation (SpO2 %)	it will be assess with pulse oximeter	once a day, before and after 1 minute sit to stand test, up to 7 day
mBorg Score	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).	once a day, before and after 1 minute sit to stand test, up to 7 day

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli
• Investigators: Principal Investigator: marco cotti, pt, IOR - Istituto Ortopedico Rizzoli

Publications and helpful links

General Publications

• Mori S, Shibazaki T, Noda Y, Kato D, Nakada T, Asano H, Matsudaira H, Ohtsuka T. Recovery of pulmonary function after lung wedge resection. J Thorac Dis. 2019 Sep;11(9):3738-3745. doi: 10.21037/jtd.2019.09.32.
• Bohannon RW, Crouch R. 1-Minute Sit-to-Stand Test: SYSTEMATIC REVIEW OF PROCEDURES, PERFORMANCE, AND CLINIMETRIC PROPERTIES. J Cardiopulm Rehabil Prev. 2019 Jan;39(1):2-8. doi: 10.1097/HCR.0000000000000336.
• Vaidya T, de Bisschop C, Beaumont M, Ouksel H, Jean V, Dessables F, Chambellan A. Is the 1-minute sit-to-stand test a good tool for the evaluation of the impact of pulmonary rehabilitation? Determination of the minimal important difference in COPD. Int J Chron Obstruct Pulmon Dis. 2016 Oct 19;11:2609-2616. doi: 10.2147/COPD.S115439. eCollection 2016.
• Tremblay Labrecque PF, Harvey J, Nadreau E, Maltais F, Dion G, Saey D. Validation and Cardiorespiratory Response of the 1-Min Sit-to-Stand Test in Interstitial Lung Disease. Med Sci Sports Exerc. 2020 Dec;52(12):2508-2514. doi: 10.1249/MSS.0000000000002423.
• Kohlbrenner D, Benden C, Radtke T. The 1-Minute Sit-to-Stand Test in Lung Transplant Candidates: An Alternative to the 6-Minute Walk Test. Respir Care. 2020 Apr;65(4):437-443. doi: 10.4187/respcare.07124. Epub 2019 Oct 22.
• Tarrant BJ, Robinson R, Le Maitre C, Poulsen M, Corbett M, Snell G, Thompson BR, Button BM, Holland AE. The Utility of the Sit-to-Stand Test for Inpatients in the Acute Hospital Setting After Lung Transplantation. Phys Ther. 2020 Jul 19;100(7):1217-1228. doi: 10.1093/ptj/pzaa057.
• Bijur PE, Latimer CT, Gallagher EJ. Validation of a verbally administered numerical rating scale of acute pain for use in the emergency department. Acad Emerg Med. 2003 Apr;10(4):390-2. doi: 10.1111/j.1553-2712.2003.tb01355.x.
• Weiner P, Man A, Weiner M, Rabner M, Waizman J, Magadle R, Zamir D, Greiff Y. The effect of incentive spirometry and inspiratory muscle training on pulmonary function after lung resection. J Thorac Cardiovasc Surg. 1997 Mar;113(3):552-7. doi: 10.1016/S0022-5223(97)70370-2.
• Schnapp LM, Cohen NH. Pulse oximetry. Uses and abuses. Chest. 1990 Nov;98(5):1244-50. doi: 10.1378/chest.98.5.1244.
• Rossi L, Boffano M, Comandone A, Ferro A, Grignani G, Linari A, Pellegrino P, Piana R, Ratto N, Davis AM. Validation process of Toronto Exremity Salvage Score in Italian: A quality of life measure for patients with extremity bone and soft tissue tumors. J Surg Oncol. 2020 Mar;121(4):630-637. doi: 10.1002/jso.25849. Epub 2020 Jan 19.
• Vijayamurugan N, Bakhshi S. Review of management issues in relapsed osteosarcoma. Expert Rev Anticancer Ther. 2014 Feb;14(2):151-61. doi: 10.1586/14737140.2014.863453. Epub 2013 Nov 26.
• Wyser C, Stulz P, Soler M, Tamm M, Muller-Brand J, Habicht J, Perruchoud AP, Bolliger CT. Prospective evaluation of an algorithm for the functional assessment of lung resection candidates. Am J Respir Crit Care Med. 1999 May;159(5 Pt 1):1450-6. doi: 10.1164/ajrccm.159.5.9809107.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2022
• Primary Completion (Actual): January 8, 2024
• Study Completion (Actual): January 8, 2024

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: March 25, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: early recovery; pulmonary rehabilitation; wedge resection
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Bone Neoplasms
• Other Study ID Numbers: WEDGE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No