Clinical and Sonographic Diaphragm Evaluation Post-plication

NCT04052295 | Completed

• 1 other identifier: South Valley University 1576
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Diaphragmatic Plication; Unilateral Diaphragmatic Paralysis; Diaphragm Ultrasonography

Keywords

Diaphragmatic eventration; Diaphragm; Dyspnea

Outcome Measures

Primary Outcomes (3)

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

  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.

  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.

  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 Outcomes (1)

• 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.

Interventions

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.

Eligibility Criteria

• Age: 21 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- Symptomatic unilateral diaphragmatic paralysis.

You may not qualify if:

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

Sponsors & Collaborators

• South Valley University: lead

MeSH Terms

Conditions

Diaphragmatic Eventration; Dyspnea

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: August 9, 2019
• Study Start: January 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: January 30, 2020
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share