NCT03804385

Brief Summary

the different surgical management in patients with primary pneumothorax 0 Objective 1: Identify risk factors that are predictive of the need for surgical intervention.

  • Objective 2: Determine the value of management strategies in terms of hospital stay
  • Objective 3: Assess outcomes and postoperative results including symptom relive ,or recurrence or post-operative complications .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

May 9, 2018

Completed
8 months until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

1.3 years

First QC Date

May 9, 2018

Last Update Submit

January 11, 2019

Conditions

Pneumothorax

Outcome Measures

Primary Outcomes (4)

  • Duration of Intercostal tube in days

    last more in open thoracotomy

    2 weeks

  • Duration of air leakage in days

    last more in intercostal tube than in open thoracotomy

    2 weeks

  • recurrence after one year

    by radiological intervention on after one year follow up

    one year

  • pain score

    high pain score in open thoracotomy than in intercostal tube

    1 week

Study Arms (1)

intercostal tube

OTHER

insertion of intercostal tube is surgical operation used in pneumothorax

Procedure: intercostal tube

Interventions

intercostal tubePROCEDURE

surgical operation

intercostal tube

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients presented with primary pneumothorax at Assiut University Hospital patients above 18 years and less 40 years Male or Females

You may not qualify if:

  • Patients with other chest pathology including :
  • emphysema
  • asthma,
  • acute or chronic infections
  • lung cancer,
  • congenital diseases including( cystic fibrosis, catamenial pneumothorax, or lymphangioleiomyomatosis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Medicine Assiut Univeresity

Asyut, 71621, Egypt

Location

School of Medicine Assiut Univeresity

Asyut, 71621, Egypt

Location

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Central Study Contacts

Mohamed Abdel-kader Osman Ahmed, MHD

CONTACT

+201062226639osman@med.aun.edu.eg

Mohamed Ahmed Khalil Salama Ayyad, MHD

CONTACT

+201002001932ayyad@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 9, 2018

First Posted

January 15, 2019

Study Start

March 1, 2019

Primary Completion

June 1, 2020

Study Completion

January 30, 2021

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations

EG(2)