Oesophagectomy and Chest Wall and Respiratory Function

Recruiting

• Conditions: Esophageal Cancer; Respiratory Function Loss; Esophagectomy
• Interventions: Other: 3D motion capture system; Other: Incentive spirometry; Other: Questionnaires

• Registration Number: NCT03835273
• Lead Sponsor: Imperial College London

Brief Summary

Open surgery for esophageal cancer commonly involves large incisions in the chest, associated with a high rate of pulmonary complications (30-50%). Minimally invasive approach through keyhole surgery has been shown to reduce pulmonary infections by 20%. Enhanced recovery programmes are evidence-based protocols, developed to achieve early recovery after surgery with early mobilisation and chest physiotherapy and have been shown to reduce pulmonary complication rates as well. The investigators intend to objectively measure chest wall movement using 3D motion capture system as well as a wearable measurement system to monitor chest wall movement.

Detailed Description

The study population consists of 50 healthy volunteers who have not received upper gastrointestinal surgery and 100 patients treated with surgery more than one year ago (50 open and 50 minimally invasive). Chest wall movement will be measured using a 3D optical motion system and the investigators will establish if inertial measurement units placed strategically on the chest wall are able to quantify chest expansion and lung capacity. Data will be acquired during different breathing patterns and during use of an incentive spirometry. Pulmonary function tests will be undertaken in all patients and the investigators will also collect clinical data concerning health-related quality of life and other concomitant medical conditions. The target outcome of this study is to determine whether the 3D motion capture and wearable systems are reliable in the measurement of chest wall movement after surgical removal of esophagus and the validity and patient acceptability of wearable system, as well as the ability of distinguishing open and minimally invasive surgical approach. A tailored physiotherapy may be developed following this study in order to improve chest wall movement and objectively measure this using the wearable system. This can then be implemented in a clinical trial to provide the evidence base to for patient-tailored physiotherapy following major cancer surgery and to optimise the respiratory function.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-02-06
• Study First Submitted QC: 2019-02-07
• Study First Posted: 2019-02-08
• Study Start: 2019-05-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-28
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Exposure group:

  1. Patients treated more than a year ago with oesophagectomy for oesophageal cancer, either by an open approach or minimally invasive surgery.
  2. Patients able to understand and retain the information provided, thereby being able to give informed consent for inclusion in this study.

• Control group:

  1. Healthy volunteers with no underlying respiratory disease and no history of upper gastrointestinal surgery.
  2. Individuals able to understand and retain the information provided, thereby being able to give informed consent for inclusion in this study.

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Exclusion Criteria

• Any participant who lacks capacity or is unable to provide informed consent.
• Any participant younger than 18 or older than 90 years of age.
• Any patient with evidence of cancer recurrence or on-going postoperative complication at more than one year following surgery for oesophageal cancer.
• Any pregnant participant.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Open surgery	Questionnaires	Fifty patients who have undergone open removal of oesophagus more than one year ago.
Open surgery	Incentive spirometry	Fifty patients who have undergone open removal of oesophagus more than one year ago.
Control group	Questionnaires	Fifty control participants who have not received upper gastrointestinal surgery.
Open surgery	3D motion capture system	Fifty patients who have undergone open removal of oesophagus more than one year ago.
Control group	3D motion capture system	Fifty control participants who have not received upper gastrointestinal surgery.
Control group	Incentive spirometry	Fifty control participants who have not received upper gastrointestinal surgery.

Primary Outcome Measures

Name	Time	Method
Lung function	Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.	Patients will be asked to perform incentive spirometry which is a non-invasive assessment of the lung function. The forced expiratory volume in 1 second (FEV1) and the forced vital capacity (FVC) will be recorded for all participants.
Chest wall movement	Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.	Evaluation of changes in chest wall movement in patients who have undergone oesophagectomy more than a year ago (open or minimally invasive approach) and in healthy control participants. Reflective markers will be placed on the chest wall of the participant and chest wall movement will be detected by a 3D motion capture system using these markers. In addition, inertia measurement units will be applied next to the markers. Chest wall movement will be assessed during normal breathing, take and hold a deep breath and whilst performing incentive spirometry.

Secondary Outcome Measures

Name	Time	Method
Health-related Quality of Life in patients with tumours of the oesophagus, oesophago-gastric junction or stomach	Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.	All participants will be asked to fill in a validated questionnaire, European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Oesophago-Gastric Module 25 (EORTC QLQ-OG25) for assessment of their current quality of life. The QLQ-OG25 has six symptom scales (dysphagia, eating restrictions, reflux, odynophagia, pain and discomfort, and a scale assessing anxiety) and 10 single items relevant to patients undergoing palliative or potentially curative treatments and follow-up for upper gastrointestinal cancer. All items have four-point scale, namely 'Not at all' (point 1), 'A little', 'Quite a bit' and 'Very much' (point 4). Higher scores in symptom scales represent presence of more symptoms.
Health-related Quality of Life in cancer patients	Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.	All participants will be asked to fill in a validated questionnaire, the European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30) for assessment of their current quality of life. The QLQ-C30 includes 5 functional scales, 3 symptom scales, a global health status/QoL scale, and 6 single items. Items 1 to 28 have a four-point scale response, namely 'Not at all' (point 1), 'A little', 'Quite a bit' and 'Very much' (point 4). The last 2 items have a seven-point scale for assessment of the overall health and overall quality of life, being 'Very poor' (point 1) to 'Excellent (points 7). Higher scores in the function and global quality of life scales represent better levels outcome, whilst higher scores in symptom scales represent presence of more symptoms.

Trial Locations

Locations (1)

Charing Cross Hospital; 🇬🇧 London, United Kingdom