Oesophagectomy and Chest Wall and Respiratory Function

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Imperial College London

Status

Enrolling

Conditions

Esophageal Cancer
Esophagectomy
Respiratory Function Loss

Treatments

Other: 3D motion capture system
Other: Questionnaires
Other: Incentive spirometry

Study type

Observational

Funder types

Other

Identifiers

NCT03835273
19SM5007

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Exposure group:

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

Control group:

  • 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.

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.

Trial design

100 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Karina Tukanova; Sheraz R Markar, Dr

Data sourced from clinicaltrials.gov

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