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NCT Number: NCT06972836

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amr El Sayed Tawfek, Zagazig, Sharqia Province, Egypt

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About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

modified pericardial window

Procedure

(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

traditional pericardial window

Procedure

A portion of pericardium (2 cm diameter) was resected anterior to the phrenic nerve by diathermy hook

Primary outcomes

  1. recurrence of pericardial effusion

    Time frame: follow up each month at out patient clinic for 6 months from the date of surgery

    clinical (Beck's triad:Hypotension with a narrowed pulse pressure,jugular venous distension,distant heart sounds )and Echo findings suggestive of recurrence of pericardial effusion

  2. Awake anasethia

    Time frame: from the start till the end of the procedure about 45 min

    the patient is sedated -cooperative- hemodynamically stable by transthoracic spinal anasthsia at Cervical 5

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 15, 2025
Registry last updated
May 15, 2025

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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