Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-01-01 @ 12:35 AM
Study NCT ID:
NCT04052295
Status:
COMPLETED
Last Update Posted:
2021-05-11
First Post:
2019-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Sonographic Diaphragm Evaluation Post-plication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003965', 'term': 'Diaphragmatic Eventration'}, {'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-06', 'studyFirstSubmitDate': '2019-07-24', 'studyFirstSubmitQcDate': '2019-08-07', 'lastUpdatePostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiological examination for diagnosis of diaphragmatic paralysis and the changes post surgical diaphragmatic plication for the management of unilateral diaphragmatic paralysis.', 'timeFrame': 'Chest sonography was done before operation; and follow up at one week and 6 months, through study completion, an average of 1 year .', 'description': 'The radiological investigation included; chest sonography.'}, {'measure': 'Respiratory functions test for evaluation of the changes post surgical diaphragmatic plication for the management of unilateral diaphragmatic paralysis.', 'timeFrame': 'Spirometry was done before operation; and follow up at one week and 6 months postoperatively, through study completion, an average of 1 year .', 'description': 'Spirometry was done (FEV1 in %, FVC in %, FEV1/FVC in %).'}, {'measure': 'Radiological examination for diagnosis of diaphragmatic paralysis and the changes post surgical diaphragmatic plication for the management of unilateral diaphragmatic paralysis.', 'timeFrame': '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.', 'description': 'The radiological investigation included; chest X-ray.'}], 'secondaryOutcomes': [{'measure': "Evaluation of the efficacy of surgical diaphragmatic plication and its effect on improving patients' symptoms.", 'timeFrame': 'the data were collected preoperatively as a baseline; one week and 6 months postoperatively.', 'description': 'the clinical dyspnoea evaluation according to MRC score.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diaphragmatic eventration', 'Diaphragm', 'Dyspnea'], 'conditions': ['Diaphragmatic Plication', 'Unilateral Diaphragmatic Paralysis', 'Diaphragm Ultrasonography']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'symptomatic unilateral diaphragmatic paralysis patients who underwent surgical diaphragmatic plication presented during a period from January 2015 to January 2020.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Symptomatic unilateral diaphragmatic paralysis.\n\nExclusion Criteria:\n\n* Children\n* Morbid obesity\n* Certain neuromuscular disorders\n* Previous thoracic surgical intervention on the affected\n* Recurrent eventration'}, 'identificationModule': {'nctId': 'NCT04052295', 'briefTitle': 'Clinical and Sonographic Diaphragm Evaluation Post-plication', 'organization': {'class': 'OTHER', 'fullName': 'South Valley University'}, 'officialTitle': 'Clinical and Sonographic Evaluation of the Diaphragm After Plication in Adults With Unilateral Eventration: a Retrospective Study', 'orgStudyIdInfo': {'id': 'South Valley University 1576'}}, 'armsInterventionsModule': {'interventions': [{'name': 'surgical diaphragmatic plication', 'type': 'PROCEDURE', 'description': '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.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Valley University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Mohamed Abdel Bary Ahmed Ibrahim', 'investigatorAffiliation': 'South Valley University'}}}}