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Safety and Efficacy of Awake Uniportal Video Assisted Thoracoscopic Modified Pericardial Window in Recurrent Pericardial Effusion at Mid Term Result

Z

Zagazig University

Status

Active, not recruiting

Conditions

Pericardial Effusion
Pericadiopleural Window
Awake Thoracoscope

Treatments

Procedure: modified pericardial window
Procedure: traditional pericardial window

Study type

Interventional

Funder types

Other

Identifiers

NCT06972836
ZU-IRB # 739-15-10-2024

Details and patient eligibility

About

this study compare two surgical techniues at the same time two methods of anathesia with assisstance of thoracoscope for cases of repeated collection of fluid in pericardial sac and observation the result of the two techniques on the operated patients from 3 to 6 months

Full description

this study compare two thoracoscopic techniues awake modified pericardial window and pericardial window under general anasethia for cases of repeated collection of fluid in pericardial sac and observation the result of the two techniques on the operated patients from 3 to 6 months

Enrollment

36 patients

Sex

All

Ages

25 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients who presented with recurrent massive pericardial effusion based on clinical, radiological evidence by Echo and C.T. chest

Exclusion criteria

  • hemodynamically unstable patients

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

36 participants in 2 patient groups

Awake modified pericardial window
Experimental group
Description:
H) shaped lines done by diathemy hoke above phrenic nerve then the upper and lower pericardial flabs reflelected outward in upper and lower directions respectively then 3 large clips applied on each angle of the reflected pericardial anlgles then heavy non absorbable suture is taken from the centre of the free reflected edge to adjacent upper and lower pericardium
Treatment:
Procedure: modified pericardial window
General traditional pericardial window
Active Comparator group
Description:
A portion of pericardium (2 cm diameter) was resected anterior to the phrenic nerve by diathermy hook
Treatment:
Procedure: traditional pericardial window

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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