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Completed

NCT Number: NCT04052295

Clinical and Sonographic Diaphragm Evaluation Post-plication

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).

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Symptomatic unilateral diaphragmatic paralysis.

Exclusion criteria

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

Treatment and study plan

surgical diaphragmatic plication

Procedure

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 outcomes

  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 week 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 week 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 week and 6 months postoperatively, through study completion, an average of 1 year.

    The radiological investigation included; chest X-ray.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Aug 9, 2019
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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