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: pactr.samrc.ac.za
Trial no.: PACTR201207000395469 Date of Approval: 01/07/2012
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Chest closure without drainage after open patent ductus arteriosus ligation in Ugandan children. Open label randomized controlled trial.
Official scientific title Chest closure without drainage after open patent ductus arteriosus ligation in Ugandan children. Open label randomized controlled 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 Intensive Care Unit (ICU) stay
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Patent ductus arteriosus
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 07/03/2012
Actual trial start date 25/04/2012
Anticipated date of last follow up 30/06/2013
Actual Last follow-up date 22/09/2013
Anticipated target sample size (number of participants) 86
Actual target sample size (number of participants) 62
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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 31 Active-Treatment of Control Group
Control Group drain following ligation of the patent ductus arteriosus, these patients will receive a chest drain 31 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum 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 3 Month(s) 12 Year(s) 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 constituted the following complications; significant pleural space accumulation (pleural separation >30mm) at 48 hours post operatively or need for increased postoperative oxygen supplementation (>1L/min) or drainage site infection (seen as purulent discharge at the tube drain site). 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
Uganda Heart Institute Mulago hill Kampala 256 Uganda
MEPI CVD linked project Makerere College of Health Sciences kampala 256 Uganda
Uganda Heart Institute Mulago hill Kampala 256 Uganda
MEPI CVD linked project Makerere College of Health Sciences kampala 256 Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Uganda Heart Institute Mulago hill kampala 256 Uganda Hospital
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 Street address
Principal Investigator Naomi Kebba drnaomi_k@rocketmail.com 256 787 030097 Makerere University
City Postal code Country Position/Affiliation
Kampala 256 Uganda graduate student
Role Name Email Phone Street address
Principal Investigator Naomi Kebba kebbba@yahoo.com +256 787 030097 Uganda Heart Institute
City Postal code Country Position/Affiliation
Kampala 256 Uganda Registrar
Role Name Email Phone Street address
Public Enquiries Naomi Kebba kebbba@yahoo.com 256 787 030097 Uganda Heart Institute
City Postal code Country Position/Affiliation
kampala 256 Uganda Registrar
Role Name Email Phone Street address
Scientific Enquiries Anthony Ekwaro Obuku ekwaro@gmail.com 256 312 109456 makerere university
City Postal code Country Position/Affiliation
kampala 256 Uganda research fellow
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information