Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Esophageal Cancer

Fifty control participants who have not received upper gastrointestinal surgery.

Fifty patients who have undergone open removal of oesophagus more than one year ago.

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.

3D motion capture system

Incentive spirometry is a non-invasive device for assessment of pulmonary function.

Incentive spirometry

Two 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 one non-validated satisfaction questionnaire regarding the usability and acceptability of the 3D motion capture system \[7,8\]

Questionnaires

Sheraz R Markar, Dr

Karina Tukanova

Karina Tukanova, MD

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.

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.

Oesophagectomy and Chest Wall and Respiratory Function

Changes in Respiratory Function and Chest Wall Movement Following Oesophagectomy

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.

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.

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.

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.

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.

Imperial College London

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Lung Neoplasms

Lung Diseases

Postoperative Complications

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Standard physiotherapy includes routine physiotherapy care as per current institutional standards. This consists of two daily visits by the physiotherapist. During the visits, the patient will be taught deep breathing and will be instructed to practice it 10 times every hour. They are also shown shoulder movements and lung expansion exercises. They will receive a sheet summarizing the exercises for future reference. The patient is discharged from physiotherapy when they are ambulatory, on room air, and able to clear their respiratory secretions independently, although they will be asked to continue the exercises on their own until 30 days from surgery.

Patients in the Incentive Spirometry arm will receive standard physiotherapy care in addition to training and use of an incentive spirometer. The physiotherapy care includes routine care as per current institutional standards.

They will also receive an incentive spirometer on the first postoperative day and will be taught how to use it with an accompanying instructional sheet for later reference. Teaching will emphasize slow deep breathing, sustained vacuum pressure, and gradual increase in difficulty. Patients will be instructed to use the spirometer 10 times every hour until 30 days after surgery.

Standard of care exercise training and supervision

Physiotherapy

Wael C Hanna, MDCM MBA FRCSC FCCP

After any surgery, there is a chance of complications. After lung surgery to remove tumours, there is a particularly high chance of a person developing an infection or needing help breathing, called post operative pulmonary complications. Currently, the risk of these complications is reduced through the completion of light physical and deep breathing exercises and walking around as soon as possible after surgery. Another possible way of helping these patients is to use a small device called an Incentive Spirometer to encourage and measure deep breathing. This study wants to compare how often postoperative pulmonary complications happen after major lung surgery between a group completing the exercises alone and a group using the Incentive spirometer in addition to the exercises. It is hoped that the combined therapy will reduce the amount of time patient must stay in hospital, have fewer complication events and have fewer patients re-admitted back into the hospital after they go home, so that patients overall have better outcomes.

This study is a prospective blinded randomized control trial (RCT) where two arms will be assembled. Consenting eligible patients will be randomized to either the physiotherapy + incentive spirometry (PT+IS-intervention) arm or physiotherapy only (PT-control arm). Patients will be randomized with an equal (1:1) chance of being allocated to either the PT (control) arm or PT+IS (intervention) arm. Both the treating surgeon and data interpreter will be blinded to the intervention.

Incentive Spirometry Added to Physiotherapy to Reduce Postoperative Pulmonary Complications After Lung Surgery

Incentive Spirometry Added to Physiotherapy to Reduce Postoperative Pulmonary Complications After Lung Surgery: A Prospective Blinded Randomized Trial

Postoperative pulmonary complications (PPCs) are defined as:

* Pneumonia requiring treatment with antibiotics
* Atelectasis requiring pulmonary toilet by bronchoscopy
* Respiratory failure requiring treatment via mechanical ventilation (invasive or non-invasive)
* Requirement for home oxygen after surgery, when this was not the case prior to surgery

Use of oxygen therapy required while in hospital

Re-admission to hospital due to post operative pulmonary complications

Calculated as an aggregate measure considering length of hospital stay, readmission to hospital and cost of treating complications. A cost value will be assigned to each group and compared for cost-benefit relationships

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Oesophagectomy and Chest Wall and Respiratory Function	NCT03835273	Esophageal Canc... Esophagectomy Respiratory Fun...	3D motion captu... Incentive spiro... Questionnaires	18 Years - 90 Years	Imperial College London
Incentive Spirometry Added to Physiotherapy to Reduce Postoperative Pulmonary Complications After Lung Surgery	NCT02146092	Lung Neoplasms Benign Lung Dis...	Incentive spiro... Physiotherapy	18 Years -	McMaster University

Spots Global Cancer Trial Database for incentive spirometry