Quality of Life and Pain Outcomes Following Video-Assisted Thoracic Surgery (VATS) Anatomic Lung Resection Versus Thoracotomy and Anatomic Lung Resection

Completed

• Conditions: Quality of Life; Lung Cancer; Video-assisted Thoracic Surgery (VATS); Thoracotomy
• Interventions: Behavioral: questionnaires

• Registration Number: NCT00598000
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of this study is to see if different types of surgery for lung cancer have different effects on quality of life and pain. What we learn from this study may help us find new ways to improve the quality of life of lung cancer patients who have surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2008-01-09
• Study First Submitted QC: 2008-01-09
• Study First Posted: 2008-01-18
• Status Verified: 2015-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-22
• Last Update Posted: 2015-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

• Patients with histologically confirmed or suspected clinical stage I non small cell lung cancer (including carcinoid tumors) based on standard staging (CT, PET, ± mediastinoscopy).
• Patients offered a VATS anatomic lung resection or a standard, posterolateral thoracotomy and anatomic lung resection at MSKCC.
• Patients cannot have had prior therapy, including surgery for the current lesion, systemic chemotherapy or external beam radiotherapy.
• KPS ≥ 70.
• Synchronous primaries within one lobe.

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Exclusion Criteria

• Patients who have already undergone the planned operation.
• Patients who cannot tolerate segmentectomy or lobectomy.
• Patients with locally advanced or metastatic disease found either preoperatively or at the time of operation.
• Patients who are non- English speaking
• Patients with multi-focal disease
• Patients with con-current cancers
• Patients with benign disease.
• Patients who are unwilling or unable to return to Memorial Sloan-Kettering Cancer Center for postoperative follow-up for the first year following their operation.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2	questionnaires	Determine the impact, in terms of quality of life (QOL), in traditional thoracotomy and anatomic lung resection in early stage lung cancer.
1	questionnaires	Determine the impact, in terms of quality of life (QOL), of minimally invasive, video-assisted thoracic surgery (VATS)

Primary Outcome Measures

Name	Time	Method
Determine the postoperative change in QOL and level of pain in patients with clinical stage I NSCLC undergoing VATS anatomic lung resection and for patients with clinical stage I NSCLC undergoing thoracotomy and anatomic lung resection	conclusion of study

Secondary Outcome Measures

Name	Time	Method
Compare early postoperative analgesic requirements between the VATS and thoracotomy groups.	conclusion of study

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States