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The Efficacy of Diaphragmatic Plication in Patients With Unilateral Diaphragmatic Paralysis; a Two-centre Experience

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ClinicalTrials.gov Identifier: NCT04052295
Recruitment Status : Completed
First Posted : August 9, 2019
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Mohamed Abdel Bary Ahmed Ibrahim, South Valley University

Brief Summary:
The investigators aim to evaluate the efficacy of surgical diaphragmatic plication (SDP) for the management of unilateral diaphragmatic paralysis (UDP) and its effect on improving patients' symptoms and their performance status.

Condition or disease Intervention/treatment
Diaphragmatic Plication Unilateral Diaphragmatic Paralysis Diaphragmatic Eventration Procedure: surgical diaphragmatic plication

Detailed Description:

Background:

Diaphragm eventration is not an uncommon problem, it may be asymptomatic, but most of the patients suffer from dyspnoea and deterioration of their sports activities. General practitioners are not aware of the surgical benefit, especially diaphragmatic plication.

Methods:

A retrospective analysis of all patients who underwent surgical diaphragmatic plication (SDP) at our both centres in the last 5 years (Jan. 2014-Dec. 2018). The data of all patients were obtained from hospital patients records, family doctors and personal patients contact. All patients underwent routine preoperative workup and besides chest X-ray, chest computed tomography, chest sonography, fluoroscopy and spirometry with the assessment of FEV1, FVC (forced vital capacity ), FEV1/FVC, as well as a clinical dyspnoea evaluation according to MRC (medical research council) score. These investigations were done preoperatively as a baseline, one month and 6 months postoperatively. The data were compared and the statistical analysis was done using multivariate analysis.

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Study Type : Observational
Actual Enrollment : 47 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Sonographic Assessment of the Diaphragm After Plication in Adults With Unilateral Eventration: a Two-centre Experience
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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 month and 6 months, through study completion, an average of 1 year . ]
    The radiological investigation included; chest sonography.

  2. 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 month and 6 months postoperatively, through study completion, an average of 1 year . ]
    Spirometry was done (FEV1 in %, FVC in %, FEV1/FVC in %).

  3. 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 month and 6 months postoperatively, through study completion, an average of 1 year. ]
    The radiological investigation included; chest X-ray.

  4. Radiological examination for diagnosis of diaphragmatic paralysis. [ Time Frame: Chest computed tomography and fluoroscopy were done preoperatively for diagnosis through study completion, an average of 1 year . ]
    The radiological investigation included; chest computed tomography and fluoroscopy.


Secondary Outcome Measures :
  1. Evaluation of the efficacy of surgical diaphragmatic plication and its effect on improving patients' symptoms and their performance status. [ Time Frame: the data were collected preoperatively as a baseline; one month and 6 months postoperatively. ]
    the clinical dyspnoea evaluation according to MRC score.



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Ages Eligible for Study:   21 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who underwent surgical diaphragmatic plication for unilateral diaphragmatic paralysis at our both centres in the last 5 years.
Criteria

Inclusion Criteria:

  • unilateral diaphragmatic paralysis

Exclusion Criteria:

  • 7 cases were excluded due to incomplete data
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Responsible Party: Mohamed Abdel Bary Ahmed Ibrahim, Associate professor, South Valley University
ClinicalTrials.gov Identifier: NCT04052295    
Other Study ID Numbers: South Valley University 1576
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastroschisis
Diaphragmatic Eventration
Respiratory Paralysis
Paralysis
Neurologic Manifestations
Nervous System Diseases
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical
Digestive System Abnormalities
Digestive System Diseases