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Published on: December 23, 2022
Chest closure without drainage after open patent ductus arteriosus ligation in Ugandan children: A non blinded
Naomi Kebba1,2, Tom Mwambu3,4, Michael Oketcho3,4
1Department of Surgery, School of Medicine, College of Health Sciences, Makerere University, P.O. Box 7072, Kampala, Uganda. kebbba@yahoo.com.
Insights
Closing patent ductus arteriosus (PDA) thoracotomy without a chest drain in children under six years is safe and effective. This approach may reduce post-operative complications compared to using a drain.
Area of Science:
- Pediatric Surgery
- Cardiovascular Surgery
- Clinical Trials
Background:
- Clinical equipoise exists regarding post-operative management of patent ductus arteriosus (PDA) without chest drains.
- This study evaluated outcomes of chest closure with or without a drain after PDA ligation in children at Uganda Heart Institute.
- The trial was registered retrospectively in the Pan African Clinical Trials registry (PACTR201207000395469).
Purpose of the Study:
- To evaluate and compare post-operative outcomes of chest closure with or without a drain following PDA ligation in children.
- To determine if omitting a chest drain impacts complication rates after PDA surgery.
Main Methods:
- An open-label, randomized controlled trial involving 62 children (12 years and below) diagnosed with PDA.
- Participants were randomized to thoracotomy closure with or without a chest tube.
- Primary endpoints included pleural fluid/air accumulation, increased oxygen need, or surgical site infection.
Main Results:
- Participants in the no-drain group had significantly fewer post-operative complications (uOR: 0.21, p=0.015).
- This protective effect was not statistically significant in the multivariable model (aOR: 0.07, p=0.144).
- 62 participants were enrolled; 74% were female, with a median age of 12 months.
Conclusions:
- Thoracotomy closure without a drain is safe and effective for uncomplicated PDA ligation in children under six years.
- Chest drain use was associated with increased post-operative complications in this pediatric cohort.
- Omitting chest drains may be a viable strategy to reduce complications in specific pediatric PDA cases.
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).
Conclusion:
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.
Trial Registration:
The trial was registered in the Pan African Clinical Trials registry on 1st/July/2012, retrospectively registered. Identifier number PACTR201207000395469 .
