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Perioperative SDD to Prevent Infectious Complications After Esophagectomy
Sponsor: Radboud University Medical Center
Summary
The primary aim of the PERSuaDER-trial is to evaluate the effect of SDD on infectious complications after esophagectomy, focussed on the prevention of pneumonia
Official title: PERi-operative Selective Decontamination of the Digestive Tract to Prevent Severe Infectious Complications After Esophagectomy: a Randomized Multicenter Clinical Trial in Patients with Primary Resectable Esophageal Carcinoma (cT1-4, N0-3, M0)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
854
Start Date
2024-10-21
Completion Date
2028-06-30
Last Updated
2025-03-05
Healthy Volunteers
No
Conditions
Interventions
SDD
The intervention group receives SDD treatment additional to standard care, comprising two distinct liquids for oral administration: first the 5 ml amphotericin B suspension (100 mg/ml) and subsequently the 5 ml "SDD base for suspension", containing both colistin sulphate (20 mg/ml) and tobramycin sulphate (16 mg/ml). Patients take the 5 ml amphotericin B, followed by the 5 ml "SDD base for suspension", four times daily for one week, starting three days prior to the surgery. On the day of surgery, intake is limited to an early morning and a late evening dose.
Locations (2)
UZ Leuven
Leuven, Belgium
Radboudumc
Nijmegen, Netherlands