NCT04369118

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

Efficacy Study of a Selective Chest Wall Restriction Belt in Postoperative of Lung Resection. A Multicenter, Prospective, Controlled, Randomized Study With Stratification on the Surgical Approach, Open With a Blind Analysis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
PROCEDURE	Conventional follow-up	Patients in this group benefit from conventional post-operative follow-up
DEVICE	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.

Timeline

• Start date: 2020-11-18
• Primary completion: 2024-02-29
• Completion: 2024-02-29
• First posted: 2020-04-30
• Last updated: 2024-05-17

Locations

3 sites across 1 country: France