Clinical and Sonographic Diaphragm Evaluation Post-plication

May 6, 2021 updated by: Mohamed Abdel Bary Ahmed Ibrahim, South Valley University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

symptomatic unilateral diaphragmatic paralysis patients who underwent surgical diaphragmatic plication presented during a period from January 2015 to January 2020.

Description

Inclusion Criteria:

- Symptomatic unilateral diaphragmatic paralysis.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

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.
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 .
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.
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 %).
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.
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.
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.
Time Frame: the data were collected preoperatively as a baseline; one week and 6 months postoperatively.
the clinical dyspnoea evaluation according to MRC score.
the data were collected preoperatively as a baseline; one week and 6 months postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

January 30, 2020

Study Registration Dates

First Submitted

July 24, 2019

First Submitted That Met QC Criteria

August 7, 2019

First Posted (Actual)

August 9, 2019

Study Record Updates

Last Update Posted (Actual)

May 11, 2021

Last Update Submitted That Met QC Criteria

May 6, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • South Valley University 1576

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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