๐ฌIn plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Diagnosis of primary esophageal adenocarcinoma or squamous cell carcinoma (cT1b-4a,N0-3,M0) in the mid or distal esophagus or at the level of the gastro-esophageal junction scheduled for undergoing transthoracic esophagectomy with curative intent or for esophageal reconstruction with a gastric or jejunal interposition
* Age โฅ 18 years,
* Able to give written informed consent.
Exclusion Criteria:
* Patients planned for rescue surgery,
* Patients planned for colonic interposition,
* Known or suspected pregnancy,
* Patients who have undergone upper GI surgery within 30 days before randomization,
* Unable to understand the study information, study instructions and give informed consent.
* Patients enrolled in a trial that would interact with the intervention
* Patients with a known allergy, sensitivity, or interaction to investigational medicinal product.
* Patients with known/documented colonization of Enterobacteriaceae and or Pseudomonas Aeruginosa that are resistant to both tobramycin/gentamicin and to carbapenem antibiotics
* Patients undergoing CVVH.
* Patients with documented chronic renal failure (GFR \< 15 mls/min) or who are on chronic intermittent hemo- or peritoneal dialysis,
* Women of childbearing potential at risk of pregnancy, not using adequate contraception,
* Patients with the inability to swallow the SDD
* Patients with pre-existing degenerative neuromuscular diseases like, but not limited to, myasthenia gravis or Parkinson disease).