Chest closure without drainage after open patent ductus arteriosus ligation in Ugandan children: A non blinded randomized controlled trial.
BACKGROUND
There is clinical equipoise regarding post-operative management of patients with patent ductus arteriosus (PDA) without insertion of a chest drain. This study evaluated post operative outcomes of chest closure with or without a drain following Patent Ductus Arteriosus ligation among childen at Uganda Heart Instritute (UHI).


METHODS
This was an open label randomized controlled trial of 62 children 12 years of age and below diagnosed with patent ductus arteriosus at Mulago National Teaching and Referral Hospital, Uganda. Participants were randomized in the ratio of 1:1 with surgical ligation of patent ductus arteriosus to either thoracotomy closure with a chest tube or without a chest tube. All participants received standard care and were monitored hourly for 24 hours then until hospital discharge. The combined primary endpoint consisted of significant pleural space accumulation of fluid or air, higher oxygen need or infection of the surgical site. Analysis was conducted by multivariable logistic regression analysis at 5 % significance level.


RESULTS
We enrolled 62 participants, 46 (74 %) of whom were females. Their median age was 12 months (IQR: 8-36). Participants in the no-drain arm significantly had less post-operative complications compared to the drain arm (Unadjusted odds ratio [uOR]: 0.21, 95 % CI: 0.06-0.73, p = 0.015). This "protective effect" remained without statistical significance in the multivariable regression model (Adjusted odds ratio [aOR]: 0.07, 95 % CI: 0.00-2.50, p = 0.144).


CONCLUSIONS
Children aged below 6 years with patent ductus arterious can safely and effectively have thoracotomy closure without using a drain in uncomplicated surgical ligation of the PDA. Chest drain was associated with post-operative complications.


BACKGROUND
The trial was registered in the Pan African Clinical Trials registry on 1st/July/2012, retrospectively registered. Identifier number PACTR201207000395469 .
Department of Surgery, School of Medicine, College of Health Sciences, Makerere University, P.O. Box 7072, Kampala, Uganda. kebbba@yahoo.com.|Uganda Heart Institute, Mulago National Teaching and Referral Hospital, P.O. Box 7051, Kampala, Uganda. kebbba@yahoo.com.
Naomi
http://orcid.org/0000-0002-7594-639X
N
Kebba
Department of Surgery, School of Medicine, College of Health Sciences, Makerere University, P.O. Box 7072, Kampala, Uganda.|Uganda Heart Institute, Mulago National Teaching and Referral Hospital, P.O. Box 7051, Kampala, Uganda.
Tom
T
Mwambu
Department of Surgery, School of Medicine, College of Health Sciences, Makerere University, P.O. Box 7072, Kampala, Uganda.|Uganda Heart Institute, Mulago National Teaching and Referral Hospital, P.O. Box 7051, Kampala, Uganda.
Michael
M
Oketcho
Institute of Public Health and Management, International Health Sciences University, P. O. Box 7782, Kampala, Uganda.|Department of Anatomy, Uganda Society for Health Scientists, Makerere University College of Health Sciences, Kampala, Uganda.
Jonathan
J
Izudi
Clinical Epidemiology Unit, Department of Medicine, School of Medicine, College of Health Sciences, Makerere University, P.O. Box 7072, Kampala, Uganda.|Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, University of London, Keppel St, London, WC1E 7HU, UK.
Ekwaro A
EA
Obuku
Chest drain; Ligation; Patent ductus arteriosus
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