Oesophagectomy and Chest Wall and Respiratory Function
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorImperial College London
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients treated more than a year ago with oesophagectomy for oesophageal cancer, by an open approach.
Patients able to understand and retain the information provided, thereby being able to give informed consent for inclusion in this study.
Healthy volunteers with no underlying respiratory disease and no history of upper gastrointestinal surgery.
Individuals able to understand and retain the information provided, thereby being able to give informed consent for inclusion in this study.
Disqualifiers
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.
Trial population
Three cohorts will be studied, equal in size. A total of 100 patients will be included in this study. One hundred patients who have undergone oesophagectomy for oesophageal cancer more than a year ago, 60 patients who have undergone open surgery and 40 healthy volunteers will be included as a control group with no underlying respiratory disease and no previous history of upper gastrointestinal surgery. Patients who have undergone oesophagectomy will be identified from existing databases by the direct care team of the patient. Healthy volunteers will be recruited from Imperial College through paper adverts.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
3D motion capture system
Other interventionSmall reflective markers and inertia measurement units will be placed on the chest of the patients using hypoallergenic adhesive and a motion capture system will pick up a 3D image via these markers non-invasively.
Incentive spirometry
Other interventionIncentive spirometry is a non-invasive device for assessment of pulmonary function.
Questionnaires
Other interventionThree validated, European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30) and Oesophago-Gastric Module 25 (EORTC QLQ-OG25) and LASORS questionnaire.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Control group3 interventions
Group B: Open surgery3 interventions
Trial outcomes
Primary outcomes
1
Chest wall movement
Evaluation of changes in chest wall movement in patients who have undergone oesophagectomy more than a year ago (open surgery) 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.
Time frame
Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.2
Lung function
Patients will be asked to perform incentive spirometry which is a non-invasive assessment of the lung function. Spirometry (tidal breathing, forced vital capacity) and respiratory muscle strength will be recorded for all participants.
Time frame
Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.Secondary outcomes
1
Health-related Quality of Life in cancer patients
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. Similarly, the EORTC QLQ-25 comprises of questionnaires to assess the quality of life. LASORS questionnaire assesses the long-term deficits in quality of life in this population.
Time frame
Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.2
Health-related Quality of Life in patients with tumours of the oesophagus, oesophago-gastric junction or stomach
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.
Time frame
Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.Other outcomes
1
Usability and acceptability of the measuring device
All participants will be asked to fill in a satisfaction questionnaire regarding the usability and acceptability of the 3D motion capture system. This questionnaire includes a total of 10 items assessing the usability and acceptability of the 3D motion capture system. Each item has a five-point Likert scale response, with 'Strongly disagree' (point 1), 'Disagree', 'Neutral', 'Agree' and 'Strongly agree' (point 5). Higher scores correspond with better outcome.
Time frame
Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.Sponsors and contacts
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Source ClinicalTrials.gov