Uniportal VATS Resection for Pulmonary Aspergilloma : Eva... | NCT06564727

Studies
Uniportal VATS Resection for Pulmonary Aspergilloma : Evaluation of Prognostic Factors in a Single Center Experience

NCT06564727

Sponsor

Hassan II University

Status

Completed

Last Update Posted

Aug 21, 2024Actual

Enrollment

51Actual

Phase

Not Applicable

Conditions

Pulmonary Aspergillosis
Surgery-Complications
Thoracic Diseases

Interventions

Uniportal VATS approach
VATS 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

Aug 2024

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 1, 2017Actual

Primary Completion Date

Jan 1, 2020Actual

Completion Date

Jan 30, 2020Actual

First Submitted Date

Aug 14, 2024

First Submission Date that Met QC Criteria

Aug 19, 2024

First Posted Date

Aug 21, 2024Actual

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

Aug 19, 2024

Last Update Posted Date

Aug 21, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 objective of this study was to report our experience with U-VATS resection and to evaluate our surgical outcomes with an analysis of postoperative complications. The investigators also estimate the prognostic factors that influence the morbidity and the conversion.

Detailed Description

Evaluation of prognostic factors Tuberculosis Hemoptysis Type of aspergilloma presence of complete adherence Procedure

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

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Uniportal VATS approach	Experimental	patient treated by Uniportal VATS technique	Procedure: Uniportal VATS approach
VATS resection	Active Comparator	patients treated by VATS technique	Procedure: VATS approach

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Uniportal VATS approach	Procedure	Uniportal VATS resection for simple pulmonary aspergilloma	Uniportal 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:

- Treatment using uniportal VATS

Exclusion Criteria:

- Resection using thoracotomy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

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
D055732	Pulmonary Aspergillosis
D013896	Thoracic Diseases

Ancestor Terms

ID	Term
D001228	Aspergillosis
D009181	Mycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided