Exploring Robotic-assisted Thoracic Surgery for Lung Cancer

NCT03658083 | Completed

• 1 other identifier: 228/16
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 2

Brief Summary

Background Surgery for lung cancer can be performed using open (thoracotomy) or minimally invasive techniques (Video Assisted Thoracic Surgery (VATS)). Despite being associated with fewer postoperative complications (PPCs) VATS is difficult to perform and is only used by 20-44% of thoracic surgeons in the UK. Robotic-Assisted Thoracic Surgery (RATS) maybe a more attractive minimally invasive approach. To date, no studies have explored the impact of RATS on exercise capacity or physical activity and although 1 study has looked at Heath Related Quality of Life (HRQOL) post-RATS compared to an open technique indicators of surgical technique were not controlled for. Furthermore, investigators have little understanding of patients' experience of RATS. Aims

1. 1.To examine the variability of change in exercise capacity and health-related quality of life (HRQOL) between those who receive thoracotomy V RATS.
2. 2.To compare the difference in post-operative physical activity (step and activity count), across 7 days, in those who receive thoracotomy V RATS.
3. 3.To explore the manner in which patients appraise their experience of undergoing RATS.

Conditions

Lung Cancer; Thoracic Cancer; Surgery

Keywords

exercise; physical activity; quality of life; qualitative; recovery

Outcome Measures

Primary Outcomes (1)

• Change in exercise capacity assessed using the Incremental Shuttle Walk Test (ISWT)

  Distance walked in meters

  Baseline to 4-6 weeks post-surgery (visit 2)

Secondary Outcomes (9)

• Change in physical activity assessed using an Activity Monitor

  Immediately post-surgery to 1-week post-discharge

• Change in health related quality of life assessed using self-reported questionnaire

  Baseline to 3-6 days post-surgery (visit 1)

• Change in disease-specific health related quality of life assess using a self-reported questionnaire

  Baseline to 3-6 days post-surgery (visit 1)

• Change in Health related quality of life assessed using self-reported questionnaire

  Baseline to 4-6 weeks post-surgery (visit 2)

• Change in disease-specific health related quality of life assessed using self-reported questionnaire

  Baseline to 4-6 weeks post-surgery (visit 2)

Other Outcomes (3)

• Length of hospital stay

  3month follow up

• Hospital readmissions

  3month follow up

• Post-operative pulmonary complications

  3month follow up

Study Arms (2)

Thoracotomy

Individuals referred for a lung resection via thoracotomy with a primary or secondary diagnosis of lung cancer. Those with a tumor \>7cm will be excluded.

Procedure: Thoracotomy

Robotic-assisted thoracic surgery

Individuals referred for a lung resection via robotic-assisted thoracic surgery with a primary or secondary diagnosis of lung cancer. Those with a tumor \>7cm will be excluded.

Procedure: Robotic-assisted thoracic surgery

Interventions

Thoracotomy PROCEDURE

Open surgery

Thoracotomy

Robotic-assisted thoracic surgery PROCEDURE

Minimally invasive surgery

Robotic-assisted thoracic surgery

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals referred for a lung resection with a primary or secondary diagnosis of lung cancer will be eligible, although those with a tumor \>7cm will be excluded. Individuals referred for a lung resection via thoracotomy will be recruited from James Cook University Hospital and those referred for RATS will be recruited from James Cook University Hospital or the Barts Health.

You may qualify if:

• Individuals referred for a lung resection via thoracotomy or RATS with a primary or secondary diagnosis of lung cancer

You may not qualify if:

• Tumor \>7cm

Sponsors & Collaborators

• Teesside University: lead
• South Tees Hospitals NHS Foundation Trust: collaborator
• Barts & The London NHS Trust: collaborator

Study Sites (2)

Barts Health NHS Trust

London, United Kingdom

Location

James Cook University Hospital

Middlesbrough, United Kingdom

Location

MeSH Terms

Conditions

Lung Neoplasms; Motor Activity

Interventions

Thoracotomy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Thoracic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Samantha Harrison

  Teesside University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader in research

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: September 5, 2018
• Study Start: October 12, 2017
• Primary Completion: November 18, 2019
• Study Completion: November 20, 2019
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)