PERi-operative Selective Decontamination of the digestive tract to prevent severe infectious complications after Esophageal Resection: study protocol of the PERSuaDER-trial, a multicenter randomized controlled trial in patients with primary resectable esophageal carcinoma
Abstract
Esophagectomy is a highly complex surgical procedure, and it is associated with significant morbidity and mortality. The postoperative complication rate is high, with pneumonia being the most common. These are thought to arise from (micro-)aspiration of bacteria residing in the oropharyngeal and gastrointestinal (GI) tract. Selective decontamination of the digestive tract (SDD) is a prophylactic antibiotic strategy aimed at preventing these infections. SDD decolonizes the oropharyngeal and GI tract from pathogenic aerobic gram-negative rods, fungi and yeasts, while anaerobic, protective microbiota are preserved. The PERSuaDER trial aims to evaluate whether perioperative SDD can reduce postoperative pneumonia after esophagectomy. The PERSuaDER-trial is a randomized, controlled, open-label, superiority, multicenter, pragmatic, group-sequential trial aiming to include 854 patients with primary resectable esophageal carcinoma ((y)cT1-4a N0-3 M0) scheduled for transthoracic esophagectomy. The intervention group will receive SDD prophylaxis in addition to the standard care regimen. The SDD treatment comprises two oral liquids: an oral suspension containing amphotericin B and an oral solution containing both colistin sulfate and tobramycin. Participants are required to swallow the SDD suspension four times a day for 1 week, starting 3 days prior to the surgical procedure, with two doses on the day of surgery. All other aspects of care are identical to those provided to the control…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 854 participants or records.
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