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Exploring Robotic-assisted Thoracic Surgery for Lung Cancer

NCT03658083 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2022-04-27

No results posted yet for this study

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. To examine the variability of change in exercise capacity and health-related quality of life (HRQOL) between those who receive thoracotomy V RATS.
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. To explore the manner in which patients appraise their experience of undergoing RATS.

Methods:

A mixed-method, multi-center study will be undertaken, utilizing a prospective quasi-experimental study design and an interpretive phenomenological approach. 80 individuals, referred for a lung lobectomy with a primary or secondary diagnosis of lung cancer, will complete outcomes assessed at 4 time-points. The Incremental Shuttle Walk Test (ISWT) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) and the EORTC Lung Cancer module (EORTC QLQ LC13) will be completed at: baseline, 3-6 days post surgery, 6-weeks post-surgery and at 3-month follow up. Patients will wear an activity monitor immediately post-surgery until 1-week post-discharge. Step and activity counts will be recorded. In-depth interviews will be conducted with up to 15 patients who underwent RATS to explore the manner in which patients appraise their experience of RATS.

Conditions

Interventions

PROCEDURE

Thoracotomy

Open surgery

PROCEDURE

Robotic-assisted thoracic surgery

Minimally invasive surgery

Sponsors & Collaborators

  • South Tees Hospitals NHS Foundation Trust

    collaborator OTHER

  • Barts & The London NHS Trust

    collaborator OTHER

  • Teesside University

    lead OTHER

Principal Investigators

  • Samantha Harrison · Teesside University

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-12
Primary Completion
2019-11-18
Completion
2019-11-20

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03658083 on ClinicalTrials.gov