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

NCT ID: NCT06972836

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-20
• Study Completion Date: 2025-10-31

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

Detailed 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

Conditions

Awake Thoracoscope; Pericardial Effusion; Pericadiopleural Window

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Awake modified pericardial window

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

Group Type: EXPERIMENTAL

modified pericardial window

Intervention Type: 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

General traditional pericardial window

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

Group Type: ACTIVE_COMPARATOR

traditional pericardial window

Intervention Type: PROCEDURE

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

Interventions

modified pericardial window

(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

Intervention Type: PROCEDURE

traditional pericardial window

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Amr Elsayed Tawfek Ibrahim

assisstant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amr Tawfek, as prof

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Amr El Sayed Tawfek

Zagazig, Sharqia Province, Egypt

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

Zagazig, Sharqia Province, Egypt

Countries

Egypt

Other Identifiers

ZU-IRB # 739-15-10-2024

Identifier Type: -

Identifier Source: org_study_id