Clinical and Sonographic Diaphragm Evaluation Post-plication

Study Overview
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Brief Summary
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Objectives: We aim to clarify the role of diaphragm ultrasonography (DUS) in evaluating the outcome of surgical diaphragmatic plication (SDP) in adults with symptomatic unilateral diaphragmatic paralysis (UDP).

Official Title
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Clinical and Sonographic Evaluation of the Diaphragm After Plication in Adults With Unilateral Eventration: a Retrospective Study

Conditions
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Diaphragmatic Plication, Unilateral Diaphragmatic Paralysis, Diaphragm Ultrasonography

Intervention / Treatment
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* Procedure: surgical diaphragmatic plication


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Symptomatic unilateral diaphragmatic paralysis. Exclusion Criteria: Children Morbid obesity Certain neuromuscular disorders Previous thoracic surgical intervention on the affected Recurrent eventration

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: surgical diaphragmatic plication|The plication was done by the same surgeon either via a 7-8 cm long lateral thoracotomy and entrance to the pleural cavity through the eighth intercostals space on the affected side or using VATS (video-assisted thoracoscopic surgery) procedure. It was performed under single lumen intubation general anaesthesia. The diaphragm with the abdominal content was pushed caudally till the normal position of the copula achieved. At this position a fold of about 5 cm is made using traction forceps of the reluctant diaphragm. Polypropylene sutures (zero or 1) were used to perform the plication of the diaphragm. in making a fold on itself. The plication was performed using interrupted polypropylene U-stitches; usually, it started from posterior part to the anterior part of the diaphragm. We merged every two rows with continuous polypropylene sutures. The diaphragm became tough and firm and returned to its normal position. An intercostal tube was inserted, and the thoracotomy was closed in layers.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological examination for diagnosis of diaphragmatic paralysis and the changes post surgical diaphragmatic plication for the management of unilateral diaphragmatic paralysis. | The radiological investigation included; chest sonography. | Chest sonography was done before operation; and follow up at one week and 6 months, through study completion, an average of 1 year . | 
| Respiratory functions test for evaluation of the changes post surgical diaphragmatic plication for the management of unilateral diaphragmatic paralysis. | Spirometry was done (FEV1 in %, FVC in %, FEV1/FVC in %). | Spirometry was done before operation; and follow up at one week and 6 months postoperatively, through study completion, an average of 1 year . | 
| Radiological examination for diagnosis of diaphragmatic paralysis and the changes post surgical diaphragmatic plication for the management of unilateral diaphragmatic paralysis. | The radiological investigation included; chest X-ray. | Chest X-ray was done before operation; and follow up at one week and 6 months postoperatively, through study completion, an average of 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the efficacy of surgical diaphragmatic plication and its effect on improving patients' symptoms. | the clinical dyspnoea evaluation according to MRC score. | the data were collected preoperatively as a baseline; one week and 6 months postoperatively. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diaphragmatic eventration, Diaphragm, Dyspnea