NCT04412512

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
Last Updated

June 2, 2020

Status Verified

May 1, 2020

Enrollment Period

3.9 years

First QC Date

May 22, 2020

Last Update Submit

May 28, 2020

Conditions

Pulmonary Hydatid Cyst

Keywords

pulmonary hydatid cystvideo-assisted thoracic surgerythoracotomy

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    evaluate the complication at 30 days

    30 days

Study Arms (2)

VATS approach

EXPERIMENTAL

patients treated by VATS technique.

Procedure: VATS approach

Thoracotomy approach

ACTIVE COMPARATOR

patients treated by Thoracotomy technique

Procedure: Thoracotomy approach

Interventions

VATS approachPROCEDURE

video-assisted thoracic surgery approach

VATS approach
Thoracotomy approachPROCEDURE
Thoracotomy approach

Eligibility Criteria

Age6 Years - 81 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- all patients underwent surgery for pulmonary hydatid cyst

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hassan II University

Casablanca, 20000, Morocco

Location

MeSH Terms

Conditions

Echinococcosis, Pulmonary

Condition Hierarchy (Ancestors)

EchinococcosisCestode InfectionsHelminthiasisParasitic DiseasesInfectionsLung Diseases, ParasiticRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • sara WAGUAF

    Hassan II University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: study the effect of a treatment and evaluate outcome postoperative
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 22, 2020

First Posted

June 2, 2020

Study Start

January 1, 2016

Primary Completion

December 1, 2019

Study Completion

April 1, 2020

Last Updated

June 2, 2020

Record last verified: 2020-05

Locations

MO(1)