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

N/AActive Not RecruitingNCT06972836

Zagazig University36 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Awake Thoracoscope Pericardial Effusion Pericadiopleural Window

Interventions

modified pericardial windowPROCEDURE

(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 windowPROCEDURE

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

Eligibility

Sex: ALLMin age: 25 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (2)

Amr El Sayed Tawfek

Zagazig, Sharqia Province, Egypt

cardiothorathic surgery department -faculty of medecine-zagazig univeristy- Egypt

Zagazig, Sharqia Province, Egypt

Outcomes

Primary Outcomes

recurrence of pericardial effusion

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

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

Awake anasethia

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

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

Data from ClinicalTrials.gov

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