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Chest closure without drainage after open patent ductus arteriosus ligation in Ugandan children. Open label randomized controlled trial.

Chest closure without drainage after open patent ductus arteriosus ligation in Ugandan children. Open label randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR201207000395469
Enrollment
86
Registered
2012-07-01
Start date
2012-03-07
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patent ductus arteriosus

Interventions

Sponsors

MEPI CVD linked project
Lead Sponsor
Uganda Heart Institute
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All patients with a confirmed diagnosis of patent ductus arteriosus aged 12 years and below and whose guardians have consented

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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).

Secondary

MeasureTime frame
ICU stay beyond 24 hours from the time of post-operative admission.

Countries

Uganda

Contacts

Public ContactNaomi Kebba

Registrar

kebbba@yahoo.com256 787 030097

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026