At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- 3D motion capture system (other), Incentive spirometry (other), Questionnaires (other)
- How long the study runs
- Study runs about 63 months (dates as stated)
- About the drug or intervention
- 3D motion capture system — other: Small 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: Incentive spirometry is a non-invasive device for assessment of pulmonary function. · Questionnaires — other: Three 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.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years to 90 Years
- Who
- All
- Number of participants
- 73
- Started
- 2019-05-29
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for esophageal cancer
- • Clinical study - 73 participants
- • Open surgery for esophageal cancer commonly involves large incisions in the chest, associated with a high rate of pulmonary complications (30-50%)
Who can take part?
- • Ages 18 Years to 90 Years
- • Diagnosed with esophageal cancer
Where?
- • London - Charing Cross Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
More detail
The study population consists of 40 healthy volunteers who have not received upper gastrointestinal surgery and 60 patients treated with surgery more than one year ago (open approach). 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.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 90 Years
- Who can join: All genders
What the study is looking for
- ✓Exposure group:
- ✓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 agreement to take part for...
- ✓Control group:
- ✓Healthy volunteers with no underlying respiratory disease and no history of upper gastrointestinal surgery.
Who cannot take part
- ✗Any participant who lacks capacity or is unable to provide agreement to take part.
- ✗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...
- ✗Any pregnant participant.
- ✗unable to or excluded from performing spirometry or respiratory muscle strength testing (non-invasive testing)
See the full criteria
Where Is This Study? (1 UK site)
Charing Cross Hospital
London W6 8RF, United Kingdom
