Clinical and Sonographic Diaphragm Evaluation Post-plication

Completed

• Conditions: Unilateral Diaphragmatic Paralysis; Diaphragmatic Plication; Diaphragm Ultrasonography

• Registration Number: NCT04052295
• Lead Sponsor: South Valley University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2019-07-24
• Study First Submitted QC: 2019-08-07
• Study First Posted: 2019-08-09
• Primary Completion: 2019-12-01
• Study Completion: 2020-01-30
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-06
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Symptomatic unilateral diaphragmatic paralysis.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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