Efficacy Study of a Selective Chest Wall Restriction Belt in Postoperative of Lung Resection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-18

Study Completion Date

2024-02-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conventional follow-up+chest wall restriction belt

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

Group Type EXPERIMENTAL

Conventional follow-up

Intervention Type PROCEDURE

Patients in this group benefit from conventional post-operative follow-up

Conventional follow-up+chest wall restriction belt

Intervention Type DEVICE

Patients in this group benefit from conventional post-operative follow-up. The patient wear the selective chest wall restriction belt from Day 2 (after surgery) until he ceases to need it.

conventional postoperative follow-up

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

Group Type ACTIVE_COMPARATOR

Conventional follow-up

Intervention Type PROCEDURE

Patients in this group benefit from conventional post-operative follow-up

Interventions

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Conventional follow-up

Patients in this group benefit from conventional post-operative follow-up

Intervention Type PROCEDURE

Conventional follow-up+chest wall restriction belt

Patients in this group benefit from conventional post-operative follow-up. The patient wear the selective chest wall restriction belt from Day 2 (after surgery) until he ceases to need it.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No