Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional follow-up | Procedure | — | UNRESOLVED |
| Conventional follow-up+chest wall restriction belt | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Conventional follow-up+chest wall restriction belt
- 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
- interventionNames
- Procedure: Conventional follow-up
- Device: Conventional follow-up+chest wall restriction belt
- type
- ACTIVE_COMPARATOR
- label
- conventional postoperative follow-up
- description
- Patients in this group benefit from conventional post-operative follow-up . From Day 1 to Month 1
- interventionNames
- Procedure: Conventional follow-up
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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
References
Publications (0)
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