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Clinical Trials/NCT04052295
NCT04052295
Completed
Not Applicable

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

South Valley University0 sites40 target enrollmentJanuary 1, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diaphragmatic Plication
Sponsor
South Valley University
Enrollment
40
Primary Endpoint
Radiological examination for diagnosis of diaphragmatic paralysis and the changes post surgical diaphragmatic plication for the management of unilateral diaphragmatic paralysis.
Status
Completed
Last Updated
4 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 1, 2015
End Date
January 30, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed Abdel Bary Ahmed Ibrahim

Associate professor

South Valley University

Eligibility Criteria

Inclusion Criteria

  • Symptomatic unilateral diaphragmatic paralysis.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Radiological examination for diagnosis of diaphragmatic paralysis and the changes post surgical diaphragmatic plication for the management of unilateral diaphragmatic paralysis.

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.

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.

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 .

Spirometry was done (FEV1 in %, FVC in %, FEV1/FVC in %).

Secondary Outcomes

  • 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.)

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