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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201207000395469 Date registered: 2012/07/01
TRIAL DESCRIPTION
Public title POSTOPERATIVE COMPARISON OF CHEST CLOSURE WITH OR WITHOUT A DRAIN FOLLOWING PATENT DUCTUS ARTERIOSUS LIGATION. A NON BLINDED RANDOMISED CONTROLLED CLI
Official scientific title POSTOPERATIVE COMPARISON OF CHEST CLOSURE WITH OR WITHOUT A DRAIN FOLLOWING PATENT DUCTUS ARTERIOSUS LIGATION. A NON BLINDED RANDOMISED CONTROLLED CLINICAL TRIAL.
Brief summary describing the background
and objectives of the trial
Patent ductus arteriosus is the commonest congenital cardiac lesion encountered at the cardiovascular surgical division of the Uganda Heart Institute, Mulago Hospital complex. Insertion of a chest drain post operatively to prevent pleural space accumulation is the closure technique used. This exposes the patients to tube related complications. The objectives are to compare the post-operative complications of chest cavity closure with or without the tube as well as length of hospital stay
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 2012-03-07
Actual trial start date 2012-04-25
Anticipated date of last follow up 2013-06-30
Actual date of last follow up 2013-06-30
Anticipated target sample size (number of participants) 86   
Actual target sample size (number of participants) 86   
Recruitment status Open to recruitment: actively recruiting participants
Secondary Ids Issuing authority/Trial register Links to Secondary ID

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
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 Open-label (masking not used)

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group no drain following ligation of the patent ductus arteriosus, this group will not receive a chest drain post-operatively 43
Control group drain group after ligation of the patent ductus arteriosus, these patients will receive a chest drain. 43 Active

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
All patients with a confirmed diagnosis of patent ductus arteriosus aged 12 years and below and whose guardians have consented 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 4 Months 12 Years Both

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes School of Medicine Research and Ethics Committee.
Ethics Committee Address
Street address City Postal code Country
makerere medical school, mulago Kampala 256 Uganda

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The combined primary endpoint constitutes the following complications; significant pleural space accumulation or oxygen saturations of < 92% or drainage site infection. 24 hours post operatively 48 hours post operatively
Secondary Outcome ICU stay beyond 24 hours from the time of post-operative admission. 24 hours post operatively

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Uganda Heart Institute Mulago Hospital, Mulago hill Kampala 256 Uganda

FUNDING SOURCES
Name of source Street address City Postal code Country
MEPI CVD linked project kampala 256 Uganda

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor MEPI CVD linked project mulago kampala 256 Uganda University

COLLABORATORS
Name Street address City Postal code Country
uganda heart institute mulago kampala 256 Uganda

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Naomi Kebba drnaomi_k@rocketmail.com 256 787 030097
Street address City Postal code Country Position / Affiliation
Makerere University Kampala 256 Uganda graduate student
Role Name Email Phone Fax
Public Enquiries Dr Naomi Kebba drnapmi_k@rocketmail.com 256 787 030097
Street address City Postal code Country Position / Affiliation
makerere university kampala 256 Uganda graduate student
Role Name Email Phone Fax
Scientific Enquiries Dr Anthony Ekwaro Obuku ekwaro@gmail.com 256 312 109456
Street address City Postal code Country Position / Affiliation
makerere university kampala 256 Uganda research fellow