VATS Versus Thoracotomy for Pulmonary Hydatid Disease | NCT04412512

Studies
VATS Versus Thoracotomy for Pulmonary Hydatid Disease

NCT04412512

Sponsor

Hassan II University

Status

Completed

Last Update Posted

Jun 2, 2020Actual

Enrollment

134Actual

Phase

Not Applicable

Conditions

Pulmonary Hydatid Cyst

Interventions

VATS approach
Thoracotomy approach

Countries

Morocco

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016Actual

Primary Completion Date

Dec 2019Actual

Completion Date

Apr 2020Actual

First Submitted Date

May 22, 2020

First Submission Date that Met QC Criteria

May 28, 2020

First Posted Date

Jun 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2020

Last Update Posted Date

Jun 2, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

134Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VATS approach	Experimental	patients treated by VATS technique.	Procedure: VATS approach
Thoracotomy approach	Active Comparator	patients treated by Thoracotomy technique	Procedure: Thoracotomy approach

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VATS approach	Procedure	video-assisted thoracic surgery approach	VATS approach

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative complications	evaluate the complication at 30 days	30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- all patients underwent surgery for pulmonary hydatid cyst

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

81 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
sara WAGUAF	Hassan II University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hassan II University		Casablanca		20000	Morocco

Condition Browse Module

MeSH Terms

ID	Term
D004445	Echinococcosis, Pulmonary

Ancestor Terms

ID	Term
D004443	Echinococcosis
D002590	Cestode Infections
D006373	Helminthiasis
D010272	Parasitic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided