NCT03835273

Oesophagectomy and Chest Wall and Respiratory Function

Changes in Respiratory Function and Chest Wall Movement Following Oesophagectomy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Esophageal Cancer
• Esophagectomy
• Respiratory Function Loss

Interventions

Type	Name	Description
OTHER	3D motion capture system	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.
OTHER	Incentive spirometry	Incentive spirometry is a non-invasive device for assessment of pulmonary function.
OTHER	Questionnaires	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.

Timeline

• Start date: 2019-05-29
• Primary completion: 2025-08-31
• Completion: 2025-08-31
• First posted: 2019-02-08
• Last updated: 2025-07-03

Locations

1 site across 1 country: United Kingdom