An observational study in Diaphragmatic Plication, Unilateral Diaphragmatic Paralysis and Diaphragm Ultrasonography, sponsored by South Valley University. Completed. Open to participants aged 21 Years to 69 Years. Per ClinicalTrials.gov, last updated 2021-05-11.
Sponsored by South Valley University · Observational
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).
37 studies on the registry are indexed under Respiratory Paralysis; 7 are open to participants now.
This study's enrollment of 40 is below the median of 50 across 17 observational studies indexed under Respiratory Paralysis.
Browse Respiratory Paralysis studies →South Valley University is the lead sponsor of 147 studies on the registry; 46 are open to participants now.
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symptomatic unilateral diaphragmatic paralysis patients who underwent surgical diaphragmatic plication presented during a period from January 2015 to January 2020.
Exclusion Criteria:
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.
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.
Time frame: 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 %).
Time frame: 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.
Time frame: 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.
Evaluation of the efficacy of surgical diaphragmatic plication and its effect on improving patients' symptoms.
the clinical dyspnoea evaluation according to MRC score.
Time frame: the data were collected preoperatively as a baseline; one week and 6 months postoperatively.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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South Valley University