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

NCT06972836 | Active Not Recruiting DMC

• 1 other identifier: ZU-IRB # 739-15-10-2024
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Awake Thoracoscope; Pericardial Effusion; Pericadiopleural Window

Keywords

pericardial effusion; pericardiopleural window

Outcome Measures

Primary Outcomes (2)

• 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

  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

  from the start till the end of the procedure about 45 min

Study Arms (2)

Awake modified pericardial window

EXPERIMENTAL

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

Procedure: modified pericardial window

General traditional pericardial window

ACTIVE COMPARATOR

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

Procedure: traditional pericardial window

Interventions

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

Awake modified pericardial window

traditional pericardial window PROCEDURE

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

General traditional pericardial window

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• hemodynamically unstable patients

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (2)

Amr El Sayed Tawfek

Zagazig, Sharqia Province, 44519, Egypt

Location

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

Zagazig, Sharqia Province, 44519, Egypt

Location

MeSH Terms

Conditions

Pericardial Effusion

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Amr Tawfek, as prof

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assisstant professor

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 15, 2025
• Study Start: October 20, 2024
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)