About the preSponge RCT
Preemptive endoluminal negative pressure therapy at the anastomotic site in minimally invasive transthoracic esophagectomy – An international multicenter randomized controlled trial
The aim of the multicenter preSponge RCT is to study the effect of preemptive endoluminal vacuum drainage on postoperative morbidity in high-risk patients undergoing total minimally invasive (laparoscopic / thoracoscopic) transthoracic esophagectomy (ttMIE) with gastric pull-up reconstruction and high intrathoracic anastomosis (Ivor Lewis procedure).
Eligible patients include adults with resectable esophageal cancer with high operative risk (please see the protocol) randomly assigned to ttMIE and standard intrathoracic esophago-gastric anastomosis (control group) or to ttMIE plus preemptive EVD at the anastomotic level (treatment group).
The primary endpoint will be the total postoperative length of hospital stay (including readmissions) up to 90 days of follow up. Secondary endpoints will include, among others, morbidity, and mortality rates.
Each center will be represented a maximum of three authors.
For more information, please read the preSponge RCT protocol.