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Recruiting Phase 3 NCT05865743

Perioperative SDD to Prevent Infectious Complications After Esophagectomy

Trial Parameters

Condition Esophageal Cancer
Sponsor Radboud University Medical Center
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 854
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-10-21
Completion 2027-12-31
Interventions
SDD

Brief 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

Eligibility Criteria

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 ≥ 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 resista

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