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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR201207000395469 |
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Date of registration:
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01/07/2012 |
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Primary sponsor: |
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Public title:
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POSTOPERATIVE COMPARISON OF CHEST CLOSURE WITH OR WITHOUT A DRAIN FOLLOWING PATENT DUCTUS ARTERIOSUS LIGATION. A NON BLINDED RANDOMISED CONTROLLED CLI
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Scientific title:
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POSTOPERATIVE COMPARISON OF CHEST CLOSURE WITH OR WITHOUT A DRAIN FOLLOWING PATENT DUCTUS ARTERIOSUS LIGATION. A NON BLINDED RANDOMISED CONTROLLED CLINICAL TRIAL. |
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Date of first enrolment:
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2012-04-25 |
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Target sample size:
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86 |
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Recruitment status: |
Open to recruitment: actively recruiting participa |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201207000395469 |
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Study type:
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interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,
Randomised,
simple randomisation using a randomisation table created by a software program.,
sealed opaque envelopes,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Anthony
Ekwaro Obuku |
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Address:
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makerere university
256
kampala
Uganda |
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Telephone:
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256 312 109456 |
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Email:
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ekwaro@gmail.com |
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Affiliation:
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research fellow |
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Name:
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Naomi
Kebba |
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Address:
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makerere university
256
kampala
Uganda |
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Telephone:
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256 787 030097 |
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Email:
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drnapmi_k@rocketmail.com |
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Affiliation:
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graduate student |
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Key inclusion & exclusion criteria
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Inclusion criteria: All patients with a confirmed diagnosis of patent ductus arteriosus aged 12 years and below and whose guardians have consented
Exclusion criteria: History of bronchospasm or found to have bronchospasms during pre-operative assessment.
Other combined chest surgery taking place at the time of PDA ligation.
Intraoperative damage to thoracic duct or Ductus Arteriosus
Age minimum:
4 Month
Age maximum:
12 Year
Gender:
Both
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Health Condition(s) or Problem(s) studied
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complications of chest tubes in thoracotomy
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Primary Outcome(s)
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The combined primary endpoint constitutes the following complications; significant pleural space accumulation or oxygen saturations of ` 92% or drainage site infection.
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Secondary Outcome(s)
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ICU stay beyond 24 hours from the time of post-operative admission.
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Source(s) of Monetary Support
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MEPI CVD linked project
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