Efficacy Study of a Selective Chest Wall Restriction Belt in Postoperative of Lung Resection (CTS-POP)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Lung Cancer

Treatments: Procedure: Conventional follow-up; Device: Conventional follow-up+chest wall restriction belt

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT04369118

38RC19.102

Details and patient eligibility

About

The objective of this study is to evaluate the efficacy of a new medical device in post-surgery of lung resection. The principle of this new device is based on selective chest wall restriction. This new modality of chest wall restriction is evaluated on patients in post-surgery for lung cancer.

The hypothesis is that the use of this medical device would reduce the postoperative pain and increase the efficacy of cough and expectoration. The evolution of the operated patient would be better.

Full description

The present study is the first evaluation of the efficacy of a selective chest wall restriction belt.

The efficacy will be estimate on forced expiratory volume in one second (FEV1) at D3 by comparing 2 groups: a control group of patients with conventional follow-up and an experimental group of patients with conventional follow-up and a daily wear of the selective chest wall restriction belt after surgery.

Enrollment: 94 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

• Patients with segmentectomy or lobectomy for lung cancer or lung cancer suspicious,
• Surgical approach : video-assisted thoracic surgery (VATS) or thoracotomy,
• Patients affiliated to social security or similarly regime,
• Patients who gave their consent to participate in the study.

Exclusion Criteria :

• Patients with outcomes of the pulmonary function test at the preoperative assessment : forced expiratory volume in one second (FEV1) or diffusing capacity of the lung for carbon monoxide (DLCO) > 45% predicted post-operative values and VO2max (maximal oxygen consumption) between 10 and 12 ml/kg/min,
• Patients with a waist size > 120 cm
• Patients with medical treatment for chronic pain (neuropathic pain,...)
• Patients with tuberculosis or other pulmonary infectious pathology proven (aspergillosis, lung abscess, actinomycosis,...),
• Patients carrying a resistant germs or extended-spectrum beta-lactamase (ESBL),
• Paraplegic patients
• Patients with a diagnosed, progressive and/or uncontrolled neurological disease
• Patients with a progressive psychosis or a serious psychotic history (hospitalization)
• Patients who are in exclusion period of another interventional study
• Protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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94 participants in 2 patient groups

Conventional follow-up+chest wall restriction belt

Experimental group

Description:

Patients in this group benefit from conventional post-operative follow-up and wear the selective chest wall restriction belt in parallel. Patients in this group benefit from conventional post-operative follow-up . From Day 1 to Month 1

Treatment:

Procedure: Conventional follow-up

Device: Conventional follow-up+chest wall restriction belt

conventional postoperative follow-up

Active Comparator group

Description:

Patients in this group benefit from conventional post-operative follow-up . From Day 1 to Month 1

Treatment:

Procedure: Conventional follow-up