Clinical and Sonographic Diaphragm Evaluation Post-plication

Diaphragm Ultrasonography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04052295
• Other study ID #: South Valley University 1576
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: January 30, 2020

Study information

• Verified date: May 2021
• Source: South Valley University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 30, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 69 Years

Eligibility

Inclusion Criteria:

• Symptomatic unilateral diaphragmatic paralysis.

Exclusion Criteria:

• Children
• Morbid obesity
• Certain neuromuscular disorders
• Previous thoracic surgical intervention on the affected
• Recurrent eventration

Related Conditions & MeSH terms

• Diaphragmatic Plication
• Paralysis
• Respiratory Paralysis
• Unilateral Diaphragmatic Paralysis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
South Valley University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 .
Primary	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 .
Primary	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	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.