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VATS Versus Thoracotomy for Pulmonary Hydatid Disease (VATS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04412512
Recruitment Status : Completed
First Posted : June 2, 2020
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
Sara WAGUAF, Hassan II University

Brief Summary:

The aim of this study is to evaluate the efficacy and safety of minimally invasive surgery and compare the outcomes with patients undergoing thoracotomy in treatment of Pulmonary Hydatid Cyst.

Disease : pulmonary hydatid cyst.

Intervention:

  • Group 1 : VATS approach.
  • Group 2 : thoracotomy approach.

Condition or disease Intervention/treatment Phase
Pulmonary Hydatid Cyst Procedure: VATS approach Procedure: Thoracotomy approach Not Applicable

Detailed Description:
After being informed about the study and the approach, all patients giving written informed consent to determine eligibility for study entry.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: study the effect of a treatment and evaluate outcome postoperative
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: VATS Versus Thoracotomy for Pulmonary Hydatid Disease
Actual Study Start Date : January 2016
Actual Primary Completion Date : December 2019
Actual Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VATS approach
patients treated by VATS technique.
Procedure: VATS approach
video-assisted thoracic surgery approach

Active Comparator: Thoracotomy approach
patients treated by Thoracotomy technique
Procedure: Thoracotomy approach



Primary Outcome Measures :
  1. Postoperative complications [ Time Frame: 30 days ]
    evaluate the complication at 30 days



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 81 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- all patients underwent surgery for pulmonary hydatid cyst

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04412512


Locations
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Morocco
Hassan II University
Casablanca, Morocco, 20000
Sponsors and Collaborators
Hassan II University
Investigators
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Principal Investigator: sara WAGUAF Hassan II University
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Responsible Party: Sara WAGUAF, Principal Investigator, Hassan II University
ClinicalTrials.gov Identifier: NCT04412512    
Other Study ID Numbers: VATS for pulmonary hydatid
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sara WAGUAF, Hassan II University:
pulmonary hydatid cyst
video-assisted thoracic surgery
thoracotomy
Additional relevant MeSH terms:
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Echinococcosis
Echinococcosis, Pulmonary
Cestode Infections
Helminthiasis
Parasitic Diseases
Lung Diseases, Parasitic
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections