Actively Recruiting
Perioperative SDD to Prevent Infectious Complications After Esophagectomy
Led by Radboud University Medical Center · Updated on 2025-03-05
854
Participants Needed
2
Research Sites
192 weeks
Total Duration
On this page
Sponsors
R
Radboud University Medical Center
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Perioperative SDD to Prevent Infectious Complications After Esophagectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of primary esophageal adenocarcinoma or squamous cell carcinoma (cT1b-4a,N0-3,M0) in the mid or distal esophagus or at the gastro-esophageal junction
- Scheduled for transthoracic esophagectomy or esophageal reconstruction with gastric or jejunal interposition
- Age 18 years or older
- Able to give written informed consent
You will not qualify if you...
- Planned for rescue surgery
- Planned for colonic interposition
- Known or suspected pregnancy
- Upper GI surgery within 30 days before randomization
- Unable to understand study information and give informed consent
- Enrolled in a conflicting clinical trial
- Known allergy or sensitivity to study medications
- Colonization with bacteria resistant to tobramycin/gentamicin and carbapenem antibiotics
- Undergoing continuous venovenous hemofiltration (CVVH)
- Chronic renal failure with GFR < 15 mls/min or on dialysis
- Women of childbearing potential not using adequate contraception
- Inability to swallow the study medication
- Pre-existing degenerative neuromuscular diseases such as myasthenia gravis or Parkinson's disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
2
Radboudumc
Nijmegen, Netherlands, 6525GA
Actively Recruiting
Research Team
J
Justin Grootenhuis, MD
CONTACT
R
Research Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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