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Clinical and Sonographic Diaphragm Evaluation Post-plication

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04052295
Enrollment
40
Registered
2019-08-09
Start date
2015-01-01
Completion date
2020-01-30
Last updated
2021-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaphragmatic Plication, Diaphragm Ultrasonography, Unilateral Diaphragmatic Paralysis

Keywords

Diaphragmatic eventration, Diaphragm, Dyspnea

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).

Interventions

PROCEDUREsurgical 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.

Sponsors

South Valley University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 69 Years
Healthy volunteers
No

Inclusion criteria

\- Symptomatic unilateral diaphragmatic paralysis.

Exclusion criteria

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

Design outcomes

Primary

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

MeasureTime frameDescription
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026